ALINITY I CMV IGG REAGENT KIT

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY DEPRESSED ALINITY I CMV IGG RESULTS FOR TWO SAMPLES. THE FOLLOWING DATA WAS PROVIDED (>6 AU/ML IS REACTIVE): SID (B)(6), INITIAL RESULT 5.2 AU/ML, REPEATED 53.3 AU/ML, SID (B)(6), INITIAL RESULT 5.9 AU/ML, REPEATED 92.3 AU/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 07P42-22THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P42-24/-33, WITH 510K NUMBER K220949.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY DEPRESSED ALINITY I CMV IGG RESULTS FOR TWO SAMPLES. THE FOLLOWING DATA WAS PROVIDED (>6 AU/ML IS REACTIVE): SID (B)(6) INITIAL RESULT 5.2 AU/ML, REPEATED 53.3 AU/ML. SID (B)(6) INITIAL RESULT 5.9 AU/ML, REPEATED 92.3 AU/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, AND DEVICE HISTORY RECORD REVIEW. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. REVIEW OF TRACKING AND TRENDING DATA FOR THE ALINITY I CMV IGG ASSAY DID NOT IDENTIFY AN INCREASE IN COMPLAINTS. ADDITIONALLY, AN INCREASE IN COMPLAINT ACTIVITY WAS NOT IDENTIFIED FOR THE REAGENT LOT. DEVICE HISTORY REVIEW DID NOT IDENTIFY ISSUES ASSOCIATED WITH THE CUSTOMER¿S OBSERVATION. SENSITIVITY TESTING WAS PERFORMED USING IN-HOUSE RETAIN KITS OF ALINITY I CMV IGG REAGENT LOT 68356FZ00. ALL SPECIFICATIONS WERE MET INDICATING THE LOT IS PERFORMING ACCEPTABLY. LABELING WAS REVIEWED WHICH ADEQUATELY ADDRESSES THE CURRENT ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I CMV IGG REAGENT WAS IDENTIFIED.

Additional Manufacturer Narrative

CORRECTED INFORMATION FOUND IN SECTION H6: MEDICAL DEVICE PROBLEM CODE WAS CHANGED FROM A090810 TO A090803.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY DEPRESSED ALINITY I CMV IGG RESULTS FOR TWO SAMPLES. THE FOLLOWING DATA WAS PROVIDED (>6 AU/ML IS REACTIVE): SID (B)(6) INITIAL RESULT 5.2 AU/ML, REPEATED 53.3 AU/ML, SID (B)(6) INITIAL RESULT 5.9 AU/ML, REPEATED 92.3 AU/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.