TINA-QUANT APOLIPOPROTEIN A-1 VER.2

Additional Manufacturer Narrative

1. SUMMARY OF INVESTIGATION RESULTS: QC WAS ACCEPTABLE. THE REACTION KINETICS FOR ALL RUNS WERE ABNORMAL. REAGENT ISSUES WERE EXCLUDED AS THERE WERE NO QUESTIONABLE RESULTS FOR OTHER PATIENT SAMPLES. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. 2. SUMMARY OF FOLLOW UP/CORRECTIVE ACTIONS TAKEN: THE SAMPLE WAS REQUESTED FOR INVESTIGATION, HOWEVER, THERE WAS NO SAMPLE MATERIAL LEFT FOR THE INVESTIGATION. 3. DEVICE RETURNED TO MANUFACTURER? NO 4. DEVICE LABELED "FOR SINGLE USE?" NO 5. DEVICE REPROCESSED AND REUSED? NO

Additional Manufacturer Narrative

1. SUMMARY OF INVESTIGATION RESULTS: THE INVESTIGATION IS ONGOING. 2. SUMMARY OF FOLLOW UP/CORRECTIVE ACTIONS TAKEN: THE SAMPLE WAS REQUESTED FOR INVESTIGATION. 3. DEVICE RETURNED TO MANUFACTURER? NO. 4. DEVICE LABELED "FOR SINGLE USE?" NO. 5. DEVICE REPROCESSED AND REUSED? NO.

Description of Event or Problem

1. DESCRIBE THE EVENT: THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FOR 1 PATIENT TESTED FOR TINA-QUANT APOLIPOPROTEIN A-1 VER.2 ON A COBAS 8000 C 702 MODULE COMPARED TO TWO COMPETITOR METHODS. 2. PATIENT AGE RANGE: ASKU. 3. PATIENT WEIGHT RANGE: ASKU. 4. PATIENT SEX BREAKDOWN: ASKU. 5. PATIENT RACE BREAKDOWN: ASKU. 6. PATIENT ETHNICITY BREAKDOWN: ASKU.

Additional Manufacturer Narrative

1. SUMMARY OF INVESTIGATION RESULTS: INVESTIGATIONS PERFORMED WITH THE PATIENT SAMPLE DETERMINED THE SAMPLE CONTAINS MONOCLONAL GAMMOPATHY OF IGM-LAMBDA TYPE WITH ADDITIONAL CORRESPONDING BANDS IN THE IGG TRACE AND KAPPA TRACE. PER PRODUCT LABELING, "IN VERY RARE CASES, GAMMOPATHY, IN PARTICULAR TYPE IGM (WALDENSTRÖM¿S MACROGLOBULINEMIA), MAY CAUSE UNRELIABLE RESULTS. NO GENERAL PRODUCT ISSUE WAS FOUND, THE PRODUCT MEETS SPECIFICATION. 2. SUMMARY OF FOLLOW UP/CORRECTIVE ACTIONS TAKEN: A SAMPLE FROM THE PATIENT WAS PROVIDED FOR INVESTIGATION.