iSTAT quality check codes

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Is anyone else within the last couple months had an increase in the number of quality check codes? We've been seeing a huge jump - specifically those in the "30" range - underfilled, overfilled, cannot position. I can find no pattern - it's all meters, all lot numbers, all cartridge types. And I'm getting contacted by operators that have been doing this a long time, no history of errors and it's getting on their nerves! Wondering if it's a manufacturing issue but tech support is going to want specifics and I can't give them that. We've had no issues with LQC.

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I just reviewed the quality check codes we've received since January.  I totally agree there is a fairly large increase in those quality code.  I have a few departments who rarely get any QCC.  I've also seen an increase in those locations. 

I just got an email from someone else who has seen the same problem. I'm going to try calling istat and see what they say.

Yes, I have noticed an increase also.

Yes, I have also noticed an increase, mostly on our CG8 cartridge.  We only had one lot in use, lot W19172, so I called Abbott and reported it.  I assumed it was that lot#, but maybe it is all lot numbers. I am mailing back 2 boxes of that lot# today.

I have also noticed an increase in error codes (30's) with our G3 cartridges. Significant increase last month and this month especially with the "unable to position sample" error code.  17 in July, 10 so far this month.  Typically 3-5 of these particular errors per month.  No specific lot numbers or analyzers.Yell

Has anyone gotten a response from Abbott regarding the increased number of "quality" errors?  I have investigated and can find no link.  We had a significant increase and it is frustrating for everyone!


 


 

I'm with you Michelle! I had my team dig through lot numbers, cartridge types, operators - there's no pattern other than it occurs more in the "D" lot numbers which of course it would because we use tons of CG4s. And mostly code 31 and 36.


I called Abbott and they pretty much would not open a case because I did not have something more specific to report. I got my sales rep and a technical rep involved - not sure what they've found out yet. I'm open to any suggestions as we had 5 more overnight!

Hello All,


I just pulled up last months Quality Error log and they errors are all over the map.  So, just focusing on code #30 we have had two different lots (possibly three) of both G3+ and CG8+. With G3+ lot# D19179 showing a slight increase from the previous lot (from 1 to 5) and for CG8+ lot# W19170 showing an increase from 3 to 6.  This is among a total of 29 code #30 errors for the month across all reagents cartridges, having only 7-G3's and 9-CG8's.  While most cartridge types also had two different lots within the same month.


If you were really picking on the worst offenders, then they could be the G3+ and CG8+ cartridges. However, we also looked at the wards having these errors and our conclusion was that the vast majority of errors were "over/under fill" and occasional clot errors on floors which have regular new staff changes. All along with 30 codes randomly spread out, along with other errors as well. This is just what we have seen, since we also noticed the chatter on the ListServ.  Using Telcor, since the PWEB switch, we have been watching error code somewhat more now that the description shows up within the reports.


I had a large number of Quality Check Codes 30 and 31 in July and August from one location.  It was only on the Chem 8 cartridges.  It seemed to be specific to
one lot number H19179A.  I reported it to Abbott and sent a box of the cartridges for investigation.  I got the response back from Abbott today.  They referred me to the Analyzer Coded Messages Technical Bulletin (which I refer to daily when I review Quality
Check Codes) and said their investigation showed the lot is achieving its intended performance specifications. They also stated that no additional sites had reported Quality Check Codes 30 or 31.  I find that hard to believe when I’ve seen so many responses
about this on here.  At least I know I’m not the only one seeing this issue.


 



Marianne Rudolph, MT (ASCP)


Point of Care Coordinator


Ascension Sacred Heart Bay


615 North Bonita Avenue


Panama City, FL 32401


(850) 747-6832



 




From: Danyel Olson via POCT Listserv (Groupsite) [mailto:users+1234833@poct.groupsite.com]


Sent: Wednesday, September 04, 2019 3:50 PM

To: Rudolph, Marianne G <Marianne.Rudolph@ascension.org>

Subject: [POCT Listserv] Re: iSTAT quality check codes




 


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I also reported it to Abbott and received the same response-nobody else reported.  I reported code 30 and code 31 too.  Some of my cartridge lots at the time were W19197, W19172, W19122. We mostly use CG8 cartridges but also CG4. CHEM8 is used in the lab.

I reported 4 lots to Abbott:


G3 D19161 - sent back


G3 D19159


CG4 19149 - sent back


chem8 H19158


Have not received a response yet.


At our institution, codes 30 and 31 are usually due to operator error (clotted sample, over-filled cartridge, failure to seal the snap closure).  You mention that this happened in “one location”.  Have you investigated who the operators
were?



Yes, these were seasoned operators, no new operators and there were 22 different operators that got these codes.  The percentage for the location tripled for
a 4 week period.  I personally observe these operators running tests on a regular basis and it was not their technique.  Also, it happened on all of the analyzers.  Abbott had me run the ceramic conditioning cartridge on all of the analyzers and it did not
make a difference.  I stopped seeing the codes when we changed lot numbers so I thought it was related to the lot.



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We've noted dramatic increase in code 31's and some other codes in Sept., especially with G3+. Our Respiratory staff is complaining, and they're usually very happy with i-STAT, having used it many years. I have opened a case with Abbott, andwe may have to
switch to a different cartridge or something if this doesn't resolve.









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Did anyone get a resolution to the increased QCC? I got a response in November from APOC stating that nothing was wrong with the 2 lot numbers I sent in.


Things seemed to get a little better the end of 2019 and now all of a sudden in the first 12 days of January I have 33 code 31s and 36s. Again, all over the board on different meters, cartridges and lot numbers, and different experienced operators. I'm so tired of this!

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Danyel Olson
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