subtherapeutic heparin incidents

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Hi everyone,
         We’re seeing a pattern of subtherapeutic heparin in the cath lab involving different heparin lot numbers and products.   It’s unlikely that it’s a heparin potency issue given the different lots and products – with no other reports across the division and no FDA recalls.  I’ve consulted with our division clinical lead, who suggested we look at possible reagent issues? 
We use i-STAT ACTc . Have any of i-STAT ACTc users here noticed any issues lately?  

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Yes we are seeing this here as well! Complaints started about 2-3 months ago and I have been struggling to figure out the problem. We did duplicate analyzer studies, heparin dose curves, re-education on sampling ect... We didn't think it was the heparin for the same reason-multiple manufactures and multiple lots. I reported to Abbott. Their investigation reported:
In order to investigate your reported issue with the lot, the following testing was conducted.  Forty retained cartridges were tested in whole blood and a blood sample which simulates patients undergoing anticoagulation (heparin) therapy. 
 
APOC has observed a higher than expected rate of discrepant ACT results with ACT Celite cartridge lot R21058A. Appropriate actions will be taken via the APOC Corrective and Preventative Action system to address the issue. 

We have had another lot in house and still having issues. We just got a shipment of a new lot but to soon to tell on that one. Abbott said there were no other reports of problems so if you are reading this and have concerns please report to Abbott so they can address the issue!! 

Feel free to reach out to me.

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Elham Badamchian
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