MEDLINE

Additional Manufacturer Narrative

PER REPORT, "CUSTOMER RAN A PATIENT SAMPLE ON THE CARDINAL KIT, WHICH CAME BACK AS POSITIVE AND IT CAME BACK AS NEGATIVE ON THE MEDLINE KIT. THEY TESTED THE SAME SAMPLE TWICE ON EACH KIT AND IT CAME BACK THE SAME (POSITIVE BOTH TIMES ON THE CARDINAL KIT, NEGATIVE BOTH TIMES ON THE MEDLINE KIT). THE TECH RAN QC ON THE KIT AND IT WORKED APPROPRIATELY. ON 4/4 WE HAD A POSITIVE SAMPLE WITH THE CARDINAL KIT WHICH WAS ALSO TESTED ON THE MEDLINE KIT (THE TECH TESTED IT TWICE ON THE MEDLINE KIT) AND IT WAS NEGATIVE ON THE MEDLINE KIT X2. WE OPENED THIS PARTICULAR KIT AND PERFORMED QC ON 2/27. NOW THAT I THINK OF IT, IT'S PROBABLY THE SAME BOX OF CASSETTES AS THE LAST DISCREPANT TEST. I ALSO HEARD BACK FROM THE PERFORMING TECH AND SHE SAID SHE WOULD HAVE RATED THE REACTION USING THE CARDINAL KIT AS MODERATELY POSITIVE. NOT SUPER STRONG, BUT NOT SO WEAK THAT SHE QUESTIONED IF IT WAS POSITIVE OR NOT. THE LOT NUMBER OF MEDLINE MONO TEST CASSETTES IS: 225B11 EXP: 9/30/2026. I JUST RAN BOTH LEVELS OF QC ON THE KIT AND QC WORKED APPROPRIATELY. WE ARE USING SERUM, COLLECTED ON A RED TOP, NO GEL TUBE." THERE WERE NO REPORTS OF DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, OR FOLLOW UP CARE. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR AGAIN. IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

Description of Event or Problem

PER REPORT, "CUSTOMER RAN A PATIENT SAMPLE ON THE CARDINAL KIT, WHICH CAME BACK AS POSITIVE AND IT CAME BACK AS NEGATIVE ON THE MEDLINE KIT. THEY TESTED THE SAME SAMPLE TWICE ON EACH KIT AND IT CAME BACK THE SAME (POSITIVE BOTH TIMES ON THE CARDINAL KIT, NEGATIVE BOTH TIMES ON THE MEDLINE KIT). THE TECH RAN QC ON THE KIT AND IT WORKED APPROPRIATELY."