D
Patient 1
A MEDICAL TECHNOLOGIST IN THE COAGULATION LAB WAS COMPARING A LOT # (JUST RECEIVED) WITH ANOTHER PREVIOUSLY USED LOT OF THE SAME PROTEIN S KIT, BY RUNNING BOTH LOTS IN PARALLEL TO TEST A PLASMA THAT HAD BEEN CONFIRMED TO BE DEFICIENT IN PROTEIN S ACTIVITY. THE TEST PLASMA HAD AN EXPECTED LEVEL OF 38% ACTIVITY; HOWEVER 2ND LOT OBTAINED 54%, WHEREAS THE 1ST LOT YIELDED 43%, THE LATTER BEING MUCH CLOSER TO THE TARGET VALUE (38%). THIS OVERESTIMATION BY 2ND LOT WAS NOT NEGLIGIBLE, AND WAS CONSIDERED TO BE DUE TO THE TEST PLASMA BEING FROM A HETEROZYGOUS PT.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: A DEVICE FROM SAME LOT WAS EVALUATED. RESULTS OF EVALUATION: UNANTICIPATED. CONCLUSION: DEVICE WAS OUT OF SPEC IN A MANNER THAT RELATES TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE RECALLED BY MANUFACTURER/DISTRIBUTOR. THE DEVICE WAS DESTROYED/DISPOSED OF.