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We removed the affected lots from service, and initiated replacement with the distributor. We are actively monitoring with providers for any bias, and will investigate further if needed. You could also do a patient audit of all samples ran using one of those lots, just to make sure there weren't any negative outcomes or any trends observed.
We removed lots and ran a patient report to see who was tested with the affected lots. This was a painful recall as there were two notifications with additional lot numbers so we needed to run through this twice. Providers were notified and charts were reviewed to see if retesting was desired, or if the patient had already been retested or has an upcoming appointment. There should be some sort of service recovery from DCA for patients who may or may not have paid for this potentially inaccurate testing.
It is insane that you are just being notified about this now! We have been dealing with this for at least 3 weeks. Basically, we pulled the affected lots (twice, since Siemens found more affected lots after doing an investigation). We stopped testing at some of our sites completely and are only now getting to doing some testing on the remaining lots to correlate with lab and give our providers faith in using the DCA again. We pulled reports from the EMR and QML to determine which patients had been tested on the affected lots and informed their providers. We will do some more comparisons of new lots with our lab method, so that the providers will once again trust the POC results.
We already had blown through the affected lots so we had to pull all patients ran. We compared their results to previous results and if >15% difference, then we notified the physician to have them redrawn. We actually didn't have as many affected as I thought would be.
Actually, we are up to TWELVE, 2 batches of 6 lot#s, which we have to go back and deal about. I think my work laptop gave up and DIED related to the Siemens reagent/cartridge lot# issue, boo hoo! One thing to those, like me, who are not working with DCA results which are connected (meaning they are not connected instruments), the exports of patient data off of the DCAs DO NOT have a field with the entire lot# on them. Only a partial lot# is in that field. THAT is my current additional component to this nightmare for us.
Also, to date, we have not received from the distributors the notice about affected lot#s. Thanking Kathleen David again for originally posting the first 6 lot#s affected so I could hunt down what was going on 3 weeks ago.
Thank you Peggy and others for this info. I have not heard from my distributor.I emailed Siemens and was not given any info except to contact my distributor. :( No bueno!
Nancy, did you appeal to your 'local' rep? or don't know who that is? I had a local rep name and went to her.
That Siemens corporate decided this is a 'problem' for the distributor to tell us about is, in my opinion, a bad decision on their end.
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To stir the pot a bit lol.. We have been having an increase in errors on our DCAs, particularly 104 and 107 (hgb errors) not a bias. I have been having our sites call Siemens if they get any errors for documentation. I wonder if these errors are related to lots because we can not figure out any other common denominator. Peggy, even the interfaced instruments don't show the whole lot number. We went with the 4 digits we could of the lot number. Has anyone else seen an increase in errors on your instruments?
I hate to bring this topic up again, but we've had more provider complaints about the DCA A1C not matching the lab. These were lots that per Siemens were acceptable, but I'm questioning that. Has anyone else had ongoing problems with DCA results?
we have DCA vantage and are having issues with QC stability any one having similar issues ?
I think my work laptop gave up and DIED related to the Siemens reagent/cartridge lot# issue, boo hoo!
One thing to those, like me, who are not working with DCA results which are connected (meaning they are not connected instruments), the exports of patient data off of the DCAs DO NOT have a field with the entire lot# on them. Only a partial lot# is in that field.
THAT is my current additional component to this nightmare for us.
Thanking Kathleen David again for originally posting the first 6 lot#s affected so I could hunt down what was going on 3 weeks ago.
Nancy, did you appeal to your 'local' rep? or don't know who that is? I had a local rep name and went to her.
That Siemens corporate decided this is a 'problem' for the distributor to tell us about is, in my opinion, a bad decision on their end.
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Peggy, even the interfaced instruments don't show the whole lot number. We went with the 4 digits we could of the lot number.
Has anyone else seen an increase in errors on your instruments?