BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C 502 MODULE

    MDR report key: 20819160 · Received December 2, 2024

    Report

    Report Number
    1823260-2024-03483
    Event Type
    Malfunction
    Date Received
    December 2, 2024
    Date of Event
    November 25, 2024
    Report Date
    December 2, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630928354
    PMA / PMN Number
    K100853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REAGENT LOT NUMBER WAS 770472. THE EXPIRATION DATE WAS NOT PROVIDED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED DUE TO THE LACK OF PROVIDED INFORMATION.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF A QUESTIONABLE APOAT (TINA-QUANT APOLIPOPROTEIN A-1 VER.2) RESULT FROM THE COBAS 8000 COBAS C 502 MODULE. THE INITIAL RESULT WAS 0 G/L. THE REPEAT RESULT WAS 0.89 G/L. THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327821 COBAS 8000 C 502 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS 04015630928354

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown