FACTOR VIII CHROMOGENIC ASSAY

Additional Manufacturer Narrative

THE CAUSE OF THE FLAGGED PLASMA N CONTROL RESULTS WITH THE F VIII REAGENT LOT 44637 IS UNKNOWN. ROOT CAUSE INVESTIGATION HAS BEEN INITIATED AND IS ONGOING. MANUFACTURER'S PRELIMINARY ANALYSIS: DURING INVESTIGATIONS, SIEMENS HEALTHCARE DIAGNOSTICS HAS OBSERVED THAT THE ABOVE MENTIONED LOT IS SHOWING AN INCREASED OCCURRENCE OF IRREGULAR CURVES WHEN USED FOR MEASUREMENT ON SYSMEX CA-/CS- INSTRUMENTS. THIS COULD LEAD UNDER CERTAIN CIRCUMSTANCES TO AN ERRONEOUSLY INCREASED RESULT WITH A FACTOR VIII CHROMOGENIC ASSAY. THE USE OF THE AFFECTED LOT ON THE BCS/ AND BCS XP SYSTEM IS NOT AFFECTED BY THIS ISSUE. SIEMENS ISSUED AN URGENT FIELD SAFETY NOTICE BR-01216 OUTSIDE THE U.S AND AN URGENT MEDICAL DEVICE CORRECTION COMMUNICATION PH-16-002.A.US WITHIN THE U.S. THE COMMUNICATION, DATED NOVEMBER 2015, WAS ENTITLED HIGHER OCCURRENCE OF IRREGULAR CURVES WITH FACTOR VIII CHROMOGENIC ASSAY LOT #44637. IT INSTRUCTED CUSTOMERS WHO HAD ORDERED THE IMPACTED LOT OF FACTOR VIII CHROMOGENIC ASSAY ON A SYSMEX CA-1500, CA-7000 IN THE U.S. AND ALSO, CS-2000I, CS-2100I, OR CS5100 INSTRUMENTS OUTSIDE THE U.S., TO DISCONTINUE USE OF LOT 44637. IT NOTIFIED CUSTOMERS THAT SOME PATIENT RESULTS MAY SHOW A POSITIVE BIAS OF MORE THAN 20% OVER THE COMPLETE MEASURING RANGE AND THAT RESULTS THAT CROSS THE MEDICAL DECISION POINTS MIGHT BE INCORRECTLY ASSESSED. FURTHER, THE LETTER STATED THAT DUE TO A DIFFERENT DETECTION PRINCIPLE, THE USE ON BCS AND BCS XP INSTRUMENTS IS NOT AFFECTED AND THAT THEY CAN CONTINUE USING THE PRODUCT ON BCS / BCS XP. SIEMENS HEALTHCARE DIAGNOSTICS IS CONTINUING TO INVESTIGATE THE ISSUE. SIEMENS WILL PROVIDE AN UPDATE TO THIS REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

THE CUSTOMER COMPLAINED OF OBTAINING "NO LINEARITY" ERROR FLAGS WITH PLASMA N CONTROL WITH THE FACTOR VIII (F VIII) REAGENT LOT 44637 ON THE CS-2000I INSTRUMENT SYSTEM. PATIENT SAMPLES WERE NOT IMPACTED. NO DISCREPANT PATIENT RESULTS WERE REPORTED TO PHYSICIANS. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED ON THE BASIS OF THE FLAGGED PLASMA N CONTROL RESULTS WITH THE F VIII REAGENT. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE FLAGGED PLASMA N CONTROL RESULTS WITH THE F VIII REAGENT.