ARCHITECT CMV IGG REAGENT KIT

Description of Event or Problem

THE FOLLOWING INCIDENCE DESCRIBES A USE ERROR. THE CUSTOMER OBSERVED FALSE NONREACTIVE ARCHITECT CMV IGG RESULTS FOR MULTIPLE SAMPLES AFTER A NEW REAGENT PACK WAS STARTED ON (B)(6) 2023. ADDITIONALLY, THE POSITIVE QUALITY CONTROL WAS OUT OF RANGE. THE FOLLOWING DATA WAS PROVIDED: PATIENT 1: INITIAL RESULT = 5.4 AU/ML (NONREACTIVE), REPEAT = 161.8 AU/ML (REACTIVE) (CORRECTED REPORT SENT TO PHYSICIAN); PATIENT 2: INITIAL RESULT = 2.8 AU/ML (NONREACTIVE), REPEAT = 119.9 AU/ML; PATIENT 3: INITIAL RESULT = 1.6 AU/ML (NONREACTIVE), REPEAT = 63.7 AU/ML; PATIENT 4: INITIAL RESULT = 0.9 AU/ML (NONREACTIVE), REPEAT = 37.7 AU/ML. THE LABORATORY STAFF DID NOT NOTICE THE DROP IN QUALITY CONTROLS (CONTROLS OUT OF RANGE) BEFORE PATIENTS WERE TESTED AND RESULTS WERE RELEASED FROM THE LAB. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

COMPLETED INFORMATION FOR SECTION A1 PATIENT IDENTIFIER: SIDS (B)(6), (B)(6), (B)(6), AND (B)(6). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

Additional Manufacturer Narrative

THE COMPLAINT INVESTIGATION FOR FALSE NONREACTIVE ARCHITECT CMV IGM RESULTS INCLUDED A SEARCH FOR SIMILAR COMPLAINTS, TRENDING DATA REVIEW, LABELING REVIEW, DEVICE HISTORY RECORDS REVIEW, AND IN HOUSE TESTING. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. TRENDING REVIEW DID NOT IDENTIFY ANY TRENDS FOR THE ISSUE FOR THE PRODUCT. DEVICE HISTORY RECORD REVIEW ON LOT 49574FN00 DID NOT IDENTIFY ANY NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE LIKELY CAUSE LOT NUMBER AND COMPLAINT ISSUE. IN-HOUSE SPECIFICITY TESTING WAS COMPLETED USING A RETAINED SAMPLE OF THE COMPLAINT LOT 49574FN00. ALL SPECIFICATIONS WERE MET AND NO FALSE REACTIVE RESULTS WERE OBTAINED, INDICATING THAT THE SPECIFICITY PERFORMANCE IS NOT IMPACTED. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE UNDER REVIEW. BASED ON THE INFORMATION WITHIN THE COMPLAINT RECORD, USE ERROR CAUSED THE ISSUE AS THE POSITIVE QUALITY CONTROL WAS OUT OF RANGE. THE LABORATORY STAFF DID NOT NOTICE THE DROP IN QUALITY CONTROLS (CONTROLS OUT OF RANGE) BEFORE PATIENTS WERE TESTED AND RESULTS WERE RELEASED FROM THE LAB. BASED ON THE INVESTIGATION ARCHITECT CMV IGM REAGENT LOT 49574FN00 IS PERFORMING AS INTENDED, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT CMV IGM REAGENT WAS IDENTIFIED.

Description of Event or Problem

THE FOLLOWING INCIDENCE DESCRIBES A USE ERROR. THE CUSTOMER OBSERVED FALSE NONREACTIVE ARCHITECT CMV IGG RESULTS FOR MULTIPLE SAMPLES AFTER A NEW REAGENT PACK WAS STARTED ON 11JUL2023. ADDITIONALLY, THE POSITIVE QUALITY CONTROL WAS OUT OF RANGE. THE FOLLOWING DATA WAS PROVIDED: PATIENT 1: INITIAL RESULT = 5.4 AU/ML (NONREACTIVE), REPEAT = 161.8 AU/ML (REACTIVE) (CORRECTED REPORT SENT TO PHYSICIAN). PATIENT 2: INITIAL RESULT = 2.8 AU/ML (NONREACTIVE), REPEAT = 119.9 AU/ML. PATIENT 3: INITIAL RESULT = 1.6 AU/ML (NONREACTIVE), REPEAT = 63.7 AU/ML. PATIENT 4: INITIAL RESULT = 0.9 AU/ML (NONREACTIVE), REPEAT = 37.7 AU/ML. THE LABORATORY STAFF DID NOT NOTICE THE DROP IN QUALITY CONTROLS (CONTROLS OUT OF RANGE) BEFORE PATIENTS WERE TESTED AND RESULTS WERE RELEASED FROM THE LAB. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.