BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISM HCV

    MDR report key: 9560085 · Received January 7, 2020

    Report

    Report Number
    1415939-2020-00004
    Event Type
    Malfunction
    Date Received
    January 7, 2020
    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

    TWO ADDITIONAL SUSPECT MEDIAL DEVICES WERE ADDED ON 07JAN2020. LOT 04127M700 IS DOCUMENTED IN MANUFACTURERS REPORT 1415939-2020-00005 LOT 05046M700 IS DOCUMENTED IN MANUFACTURERS REPORT 1415939-2020-00006 AN EVALUATION IS STILL IN PROCESS. A FOLLOW UP WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, REVIEW OF FIELD DATA, AND A REVIEW OF LABELING. NO ADVERSE TREND WAS IDENTIFIED FOR THE CUSTOMER'S ISSUE. NO RETURN PATIENT SAMPLE WAS AVAILABLE. HISTORICAL PERFORMANCE OF THE REAGENT LOT WAS EVALUATED USING WORLD WIDE DATA. THE PATIENT DATA WAS ANALYZED AND WITHIN EXPECTED LIMITS. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON ALL AVAILABLE INFORMATION AND ABBOTT DIAGNOSTICS' COMPLAINT INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    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. NO FURTHER CHANGES OR CORRECTIONS TO THE PRODUCT INFORMATION OR EVALUATION ARE NEEDED.

    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 (B)(6) RESULTS ON THE PRISM ANALYZER. TWENTY-SEVEN (27) RESULTS WERE REPEAT REACTIVE AND CONFIRMED NEGATIVE ON NAT. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22225 PRISM HCV ANTI-HCV QHM ABBOTT LABORATORIES 06088M700 00380740062996

    Patients

    Seq Age Sex Outcome Treatment
    1 1336, 1238, 1173, 1382, 1239| 1336, 1238, 1173, 1382, 1239| 1336, 1238, 1173, 1382, 1239| 1336, 1238, 1173, 1382, 1239| PRISM ANALYZERS LN 06A36-04| PRISM ANALYZERS LN 06A36-04| PRISM ANALYZERS LN 06A36-04| PRISM ANALYZERS LN 06A36-04| SNS 1267, 1410, 1381,| SNS 1267, 1410, 1381,| SNS 1267, 1410, 1381,| SNS 1267, 1410, 1381,