BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I HBSAG QUALITATIVE II REAGENT KIT

    MDR report key: 20947633 · Received December 16, 2024

    Report

    Report Number
    3008344661-2024-00154
    Event Type
    Malfunction
    Date Received
    December 16, 2024
    Date of Event
    November 29, 2024
    Report Date
    January 15, 2025
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    LOM
    UDI-DI
    00380740130404
    PMA / PMN Number
    P110029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H6 MEDICAL DEVICE PROBLEM CODE WAS UPDATED FROM A090810 TO A090803. THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, DEVICE HISTORY RECORD REVIEW, AND FIELD DATA REVIEW. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. A SEARCH FOR SIMILAR COMPLAINTS DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY FOR LOT 63337FZ00. TRENDING REVIEW DID NOT IDENTIFY ANY TRENDS REGARDING COMMONALITIES FOR LOT NUMBER 63337FZ00 AND COMPLAINT ISSUE. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES, POTENTIAL NON-CONFORMANCES, OR DEVIATIONS WITH LOT 63337FZ00 AND THE COMPLAINT ISSUE. THE OVERALL PERFORMANCE OF ALINITY I HBSAG QUALITATIVE II WAS REVIEWED USING FIELD DATA FROM CUSTOMERS WORLDWIDE. REVIEW SHOWS THAT THE MEDIAN PATIENT RESULT FOR LOT 63337FZ00 IS WITHIN ESTABLISHED LIMITS AND COMPARABLE WITH OTHER LOTS IN THE FIELD, CONFIRMING NO SYSTEMIC ISSUE FOR THE LOT. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. ALINITY I HBSAG 8P10 IS A HIGHLY SENSITIVE ASSAY WHICH MIGHT BE SUSCEPTIBLE TO INTERFERING SUBSTANCES THAT MIGHT TRIGGER POSITIVE ASSAY READINGS. THE CUSTOMER FOLLOWED PRODUCT LABELLING INSTRUCTIONS TO PERFORM A DOUBLE RE-TEST BOTH GIVING NONREACTIVE RESULTS; THEREFORE, THE SPECIMEN IS CONSIDERED NEGATIVE FOR HBSAG. PER PRODUCT LABELING, ARCHITECT HBSAG QUALITATIVE CONFIRMATORY USES THE PRINCIPLE OF SPECIFIC ANTIBODY NEUTRALIZATION TO CONFIRM THE PRESENCE OF HBSAG IN SAMPLES FOUND TO BE REPEATEDLY REACTIVE. IN THIS CASE IT IS POSSIBLE THAT THE PATIENT IS BORDERLINE REACTIVE/NONREACTIVE, AND THE CONFIRMED POSITIVE RESULT MAY BE DUE TO THE LOWER CUTOFF OF = 0.7 S/CO FOR THE CONFIRMATORY ASSAY VERSUS = 1.00 S/CO FOR THE HBSAG QUALITATIVE ASSAY. BASED ON THE INVESTIGATION THE ALINITY I HBSAG QUALITATIVE II REAGENT LOT 63337FZ00 IS PERFORMING AS INTENDED, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I HBSAG QUALITATIVE II REAGENT WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    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: 8P10-32 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER: 8P10-21/-31, WITH 510K/PMA/BLA NUMBER: P110029.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE NONREACTIVE ALINITY I HBSAG QUALITATIVE II RESULTS FOR ONE SAMPLE. THE FOLLOWING DATA WAS PROVIDED: INITIAL RESULT = 1.07 S/CO, REPEATS = 0.97 S/CO AND 0.90 S/CO % NEUTRALIZATION CONFIRMATORY RESULT = POSITIVE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE NONREACTIVE ALINITY I HBSAG QUALITATIVE II RESULTS FOR ONE SAMPLE. THE FOLLOWING DATA WAS PROVIDED: INITIAL RESULT = 1.07 S/CO, REPEATS = 0.97 S/CO AND 0.90 S/CO, % NEUTRALIZATION CONFIRMATORY RESULT = POSITIVE, NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274796 ALINITY I HBSAG QUALITATIVE II REAGENT KIT TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) LOM ABBOTT IRELAND DIAGNOSTICS DIVISION 63337FZ00 00380740130404

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ALNTY I PROCESSING MODU, 03R65-01, AI27159.| ALNTY I PROCESSING MODU, 03R65-01, AI27159.