i-STAT Error Codes
0 followers
0 Likes
Is anyone seeing an unusually high number of error codes with their i-STAT troponin cartridges? We have lot B16268A and month to date, we are already at 15.84%QCC with about 50 cartridges having Code 123 errors. I sent a box to i-STAT for investigation. Any ideas??
8 Replies
Reply
Subgroup Membership is required to post Replies
Join POCT Listserv now
Suggested Posts
| Topic | Replies | Likes | Views | Participants | Last Reply |
|---|---|---|---|---|---|
| Hemochron Sig Elite use outside of manufacturer temperature range | 0 | 0 | 38 | ||
| EPOC scanner issue post software update | 6 | 0 | 289 | ||
| PFA-100 | 0 | 0 | 119 |
Jane,
Quality check code 123 results when the quality control during the cartridge run fails to verify the presence of active immune reagents. This can also be caused by a cartridge leak or failure to close the cartridge completely.
This is quoted from a letter I received from Abbot after complaining about increased cartridges errors specifically 21, 50, 123, 128, 129, 132, 133, 134, 145, 146, 149, 150 and 151. On 3 different lots. I saw a huge jump in errors from July to Aug through Sep and Oct when the new cartridges rolled out. I group the errors by type. For Cartridge/Analyzer errors it went from around 25% to 60% error rate (overall error rate was around 8% with over 1,000+ cartridges used in ED so 60% were CTNI cartridges), with code 123 having the highest error rate.
I sent the lots back for testing and received the following reply. It is rather long so I will paraphrase.
A review of the Device History Records confirmed the cartridge lots passed release specifications..... No other sites have reported Quality Check Codes from the lots. A review of quality system information did not identify any related non-conformances. (mumbo jumbo about testing they performed saying the did not produce the codes we did) While we acknowledge that you experienced an issue with the system, the results of our investigation confirm the lots are achieving there intended performance versus our internal specifications when tested as described above.
Long story short they let my facility go back to the "legacy cartridge" and wouldn't you know it quality check codes dropped significantly. I have been working very closely with my ED since I started last January their overall error rate was above 8% it is now around 3%
I was also told at one point elevation was effecting the new cartridge. We sit at 4,705 feet. Things that make you go hmmmm.
In my humble opinion (I am a new POC by the way) there is something wrong with the new cartridges. I think it happens under actual use, obviously not during their in house testing. Make sure your users are closing the cartridge properly and carefully. I am dreading the day when we have to go back to the new style. But maybe by then enough places will have complained and they will get the issue fixed.
Chere'
Thanks, Chere' for the response. I shared this with our sales rep and i-STAT tech support. I'm afraid that like yours, the response to our investigation will be -cartridges performing to specifications, as usual. They said they will notate my request for legacy cartridge, if at all possible. It's frustrating to have this issue resulting in a lot of wastage and delays in resulting. Hopefully, they will have a resolution sooner than later. Thanks, again!
I know we have had several locations that have been having problems with the code 123 for at least 1 year!!!!! So for them to say that no other site has complained that is incorrect. It was with several lot numbers over a course of a year or so. we had problems getting them to acknowledge that there actually was a problem when we have had cartridge errors that were very repetitive
Do you use a transfer device, such as the C-pette, to fill the cartridges? Our POCT Operators use a C-pette and for CHEM8 and we haven't had any trouble. I ran a bunch of them in the Lab for a correlation and I forgot the C-pettes so I used a blunt transfer needle on a 3cc syringe. I had a dickens of a time getting the cartridges filled. I had to place the bevel in a certain spot in the sample well or the blood just wouldn't flow up into the chamber. Poor design if you ask me. I didn't know that we could even request legacy cartridges. I would go back to them in a heartbeat!
We use a transfer device from Abbott - i-STAT Dispensing Tips. It took care of the other errors in cartridge filling that we had before. These latest ones though look like they are really cartridge related.
Does anyone use capillary tubes for collection and filling their cartridges? If so, what brand?
Unless there has been a change, troponin can't be done on capillary specimens. And for Chem 8 capillary collections change it to moderate complexity.
Yes, that is true. To maintain waived status on iSTAT cartridges that have a waived option, you have to follow the waived status collection guidelines from Abbott. That was what they submitted to FDA for approval, so it is contingent upon it. It's very awkward to try and implement one cartridge with waived guidelines if the users in the same dept also use non-waived cartridges. I find it is really only beneficial if you have a department that ONLY uses waived cartridges (like a radiology dept using waived CREA only).