BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I HAVAB IGM REAGENT KIT

    MDR report key: 24701792 · Received March 26, 2026

    Report

    Report Number
    3002809144-2026-00073
    Event Type
    Malfunction
    Date Received
    March 26, 2026
    Date of Event
    March 6, 2026
    Report Date
    May 28, 2026
    Manufacturer
    ABBOTT GMBH
    Product Code
    LOL
    UDI-DI
    00380740135072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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 2R28 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 8P28, 510K K063329. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSE NONREACTIVE ALINITY I HAVAB IGM RESULTS WERE GENERATED ON THE ALINITY I PROCESSING MODULE FOR A 13-YEAR-OLD FEMALE. THE FOLLOWING DATA WAS PROVIDED (REFERENCE RANGE: < 0.80 S/CO NONREACTIVE, 0.80 TO 1.20 S/CO GRAYZONE REACTIVE, > 1.20 S/CO REACTIVE): SID: (B)(6) (PATIENT HAS CHRONIC HEPATITIS WITH AST AND ALT > 100): (B)(6) 2026 1ST RUN OF HAVAB IGM RESULTS: REAGENT LOT 74412BE00 = 7.81 S/CO (REACTIVE) REAGENT LOT 80220BE00 = 0.64 S/CO (NONREACTIVE) RESULTS GENERATED AFTER RE-CENTRIFUGING: REAGENT LOT 74412BE00 = 8.20 S/CO (REACTIVE) REAGENT LOT 80220BE00 = 0.63 S/CO (NONREACTIVE). (B)(6) 2026, 2ND RUN OF HAVAB IGM RESULTS AFTER RE-CENTRIFUGING: REAGENT LOT 74412BE00 = 7.94 S/CO (REACTIVE) REAGENT LOT 80220BE00 = 0.58 (NONREACTIVE). (B)(6) 2026, HAVAB IGM RESULTS AFTER RECALIBRATION: REAGENT LOT 74412BE00 = 7.47 S/CO (REACTIVE). (B)(6) 2026, RESULTS AFTER DILUTION USING REAGENT LOT 80220BE00 (PER THE PACKAGE INSERT: SAMPLES CANNOT BE DILUTED FOR THE ALINITY I HAVAB IGM ASSAY) 2X DILUTION 0.44 3X DILUTION 0.38 (B)(6) 2025, RESULTS AFTER USING A NEW REAGENT LOT 76354BE00: INITIAL RESULT = 3.97 S/CO REPEAT RESULT = 4.29 S/CO. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150154 ALINITY I HAVAB IGM REAGENT KIT HEPATITIS A TEST (ANTIBODY AND IGM ANTIBODY) LOL ABBOTT GMBH 80220BE00 00380740135072

    Patients

    Seq Age Sex Outcome Treatment
    1