D
Patient 1
A MEDICAL TECHNOLOGIST IN THE COAGULATION LABORATORY WAS COMPARING LOT 953124 WITH ANOTHER PREVIOUSLY USED LOT 953076 OF THE SAME KIT BY RUNNING BOTH LOTS IN PARELLEL 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 LOT 953124 OBTAINED 54%, WHEREAS THE LOT 953076 YIELDED 43%, THE LATTER BEING MUCH CLOSER TO THE TARGET VALUE (38%). THIS OVERESTIMATION BY LOT 953124 WAS NOT NEGLIBIBLE, AND WAS CONSIDERED TO BE DUE TO THE TEST PLASMA BEING FROM A HETEROZYGOUS PT. IN THE UNITED STATES THE DISTRIBUTOR HAS NOT RECEIVED ANY REPORT OF THIS NATURE ABOUT LOT 953124 AS OF THIS DATE.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.