BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    B2MG TINA-QUANT BETA2-MICROGLOBULIN

    MDR report key: 8551517 · Received April 25, 2019

    Report

    Report Number
    1823260-2019-90113
    Event Type
    Malfunction
    Date Received
    April 25, 2019
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JZG
    UDI-DI
    04015630900152
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE ISSUE WAS SOLVED BY REPLACEMENT OF THE REAGENT PACK. THE FOLLOW UP/CORRECTIVE ACTION WAS THE REAGENT PACK WAS REPLACED. NO DEVICES WERE RETURNED. THIS DEVICE IS NOT LABELED FOR SINGLE USE AND IS NOT REPROCESSED OR REUSED.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES <NOE>1</NOE> MALFUNCTION EVENTS. ERRONEOUS LOW RESULTS WERE GENERATED BY A COBAS 6000 C (501) MODULE. THE EVENTS INVOLVED 1 PATIENT WITH DISCREPANT RESULTS FOR B2MG TINA-QUANT BETA2-MICROGLOBULIN. THE PROVIDED PATIENT'S AGE WAS (B)(6). THE PATIENT WAS A FEMALE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344263 B2MG TINA-QUANT BETA2-MICROGLOBULIN BETA-2-MICROGLOBULIN IMMUNOLOGICAL TEST SYSTEM JZG ROCHE DIAGNOSTICS B2MG 356659 04015630900152

    Patients

    Seq Age Sex Outcome Treatment
    1