Description of Event or Problem · 1
A COMPLAINT WAS RECEIVED FROM AN ADVIA 1650 CUSTOMER THAT A SPECIFIC LOT OF BENZODIAZAPINE REAGENTS, LOT 56510483 WAS NOT HOLDING CALIBRATION AND THE POSITIVE QUALITY CONTROL WAS DRIFTING DOWN AND OUT OF SPEC WITHIN 3 TO 4 DAYS. IN-HOUSE INVESTIGATIONS ON THIS LOT OF MATERIAL SHOWED THAT POSITIVE CONTROLS WITH TARGET VALUES 25% ABOVE THE NOMINAL CUTOFF (200 NG/ML), TESTED POSITIVE WHEN RUN IMMEDIATELY AFTER CALIBRATION, BUT TESTED NEGATIVE WHEN RUN LESS THAN 24 HOURS LATER. GIVEN THE OBSERVED DETERIORATION IN THIS LOT OF BENZODIAZAPINE REAGENTS, THERE IS A RISK THAT A FALSE NEGATIVE RESULT COULD OCCUR BETWEEN QUALITY CONTROL RUNS (I.E. WITHIN 24 HOURS). THE MANUFACTURER OF THESE REAGENTS HAS CONFIRMED THAT LOT 56510483 IS PROBLEMATIC AND THEY HAVE NOTIFIED THEIR CUSTOMERS TO DISCONTINUE USE OF THIS LOT. THIS MDR IS BEING SUBMITTED BECAUSE A REMOTE POSSIBILITY EXISTS OF A SERIOUS ADVERSE EVENT WHERE A FALSE NEGATIVE RESULT COULD RESULT IN THE FAILURE TO TREAT A DRUG OVERDOSE APPROPRIATELY. SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS CUSTOMERS ARE BEING INFORMED TO DISCONTINUE USE OF THIS SPECIFIC LOT. THERE HAVE BEEN NO REPORTED ADVERSE EVENTS ASSOCIATED WITH COMPLAINTS RECEIVED ON THIS REAGENT LOT. WE CONTINUE TO INVESTIGATE ROOT CAUSE WITH THE MANUFACTURER AND MONITOR FIELD REPORTS FOR THE BENZODIAZAPINE ASSAY.