BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT ANTI-HCV REAGENT KIT

    MDR report key: 15222679 · Received August 13, 2022

    Report

    Report Number
    3002809144-2022-00281
    Event Type
    Malfunction
    Date Received
    August 13, 2022
    Date of Event
    July 30, 2022
    Report Date
    September 10, 2022
    Manufacturer
    ABBOTT GMBH
    Product Code
    MZO
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, ARCHITECT ANTI-HCV, LIST NUMBER: 06C37, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER: 01L79. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    AFTER FURTHER EVALUATION, THE SUSPECT MEDICAL DEVICE WAS CHANGED FROM ARCHITECT ANTI-HCV, LIST 06C37-78, ABBOTT GMBH, WIESBADEN, GERMANY TO THE ARCHITECT I2000SR PROCESSING MODULE, LIST 03M74-02, ABBOTT LABORATORIES, IRVING, TEXAS, USA. MDR NUMBER 3016438761-2022-00411-00 HAS BEEN SUBMITTED AND ALL FURTHER INFORMATION WILL BE DOCUMENTED UNDER THAT MDR NUMBER.THIS FOLLOW UP IS BEING SUBMITTED TO INCLUDE THE INITIAL CODING IN SECTION H6 FOR COMPONENT CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS THAT WERE NOT INCLUDED IN THE INITIAL REPORT.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE NONREACTIVE ARCHITECT ANTI-HCV RESULT FOR ONE PATIENT THAT DID NOT MATCH WITH THE PATIENT¿S HISTORICAL RESULTS WHICH WERE POSITIVE. NO SPECIFIC DATA OR PATIENT INFORMATION WAS PROVIDED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1817125 ARCHITECT ANTI-HCV REAGENT KIT ASSAY, ENZYME LINKED IMMUNOSORBENT, HEPATITIS C VIRUS MZO ABBOTT GMBH 35518BE01

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ARC I2000SR INST, 03M74-02, (B)(6).| ARC I2000SR INST, 03M74-02,(B)(6).