BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISM HCV

    MDR report key: 9521760 · Received December 26, 2019

    Report

    Report Number
    1415939-2019-00236
    Event Type
    Malfunction
    Date Received
    December 26, 2019
    Report Date
    February 24, 2020
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    QHM
    UDI-DI
    00380740062996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AN ERROR WAS IDENTIFIED ON FEBRUARY 13, 2020. THE INCORRECT PRODUCT CODE OF MZO (SECTION D.2B) WAS USED IN THE PREVIOUS SUBMISSIONS. THE CORRECT CODE IS QHM, THIS REPORT IS BEING SUBMITTED TO CORRECT THE PRODUCT CODE. THIS IS STILL A DUPLICATE SUBMISSION AND THE FOLLOW UP AND EVALUATION INFORMATION WAS PROVIDED IN THE FOLLOWING RELATED REPORTS: LOT 06088M700 IS DOCUMENTED IN MANUFACTURERS REPORT 1415939-2020-00004 LOT 04127M700 IS DOCUMENTED IN MANUFACTURERS REPORT 1415939-2020-00005 LOT 05046M700 IS DOCUMENTED IN MANUFACTURERS REPORT 1415939-2020-00006.

    Additional Manufacturer Narrative · 0

    THIS IS A DUPLICATE SUBMISSION AND IS NO LONGER NEEDED. THE FOLLOW UP AND EVALUATION INFORMATION WILL BE PROVIDED IN THE FOLLOWING RELATED REPORTS: LOT 06088M700 IS DOCUMENTED IN MANUFACTURERS REPORT 1415939-2020-00004 LOT 04127M700 IS DOCUMENTED IN MANUFACTURERS REPORT 1415939-2020-00005 LOT 05046M700 IS DOCUMENTED IN MANUFACTURERS REPORT 1415939-2020-00006.

    Additional Manufacturer Narrative · 0

    D4) ON 07JAN2020 THE SUSPECT MEDICAL DEVICE LOT NUMBER WAS PROVIDED AND UPDATED FROM UNKNOWN TO 04127M700. THE PRODUCT EVALUATION IS STILL IN PROCESS. A FOLLOW UP REPORT WILL BE PROVIDED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. AN EVALUATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED FALSE POSITIVE ANTI-HCV RESULTS ON THE PRISM ANALYZER. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) INITIAL 1.47, REPEAT 1.27, 1.25 S/CO, SID (B)(6) INITIAL 1.28, REPEAT 1.41, 1.42 S/CO, SID (B)(6) INITIAL 1.74, REPEAT 1.45, 1.57 S/CO. THE SAMPLES WERE NAT NEGATIVE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1314214 PRISM HCV ANTI-HCV QHM ABBOTT LABORATORIES 04127M700 00380740062996

    Patients

    Seq Age Sex Outcome Treatment
    1 LN 06A36-04 SN (B)(6)| LN 06A36-04 SN (B)(6)| LN 06A36-04 SN (B)(6)| LN 06A36-04 SN (B)(6)| PRISM ANALYZER| PRISM ANALYZER| PRISM ANALYZER| PRSIM ANALYZER