BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C 701 MODULE

    MDR report key: 20561064 · Received October 29, 2024

    Report

    Report Number
    1823260-2024-03122
    Event Type
    Malfunction
    Date Received
    October 29, 2024
    Date of Event
    October 8, 2024
    Report Date
    October 29, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    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 GLUC3 REAGENT LOT NUMBER WAS 781462. THE EXPIRATION DATE WAS NOT PROVIDED. THE FIELD ENGINEER FOUND THAT THE WASTE NEEDLE WAS LEAKING. HE PERFORMED MAINTENANCE. QC AND PRECISION STUDIES WERE PERFORMED AND THEY WERE WITHIN SPECIFICATIONS. THE ROOT CAUSE WAS DUE TO A HARDWARE COMPONENT FAILURE (LEAKING NEEDLE).

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH GLUCOSE HK GEN.3 (GLUC3) ASSAY ON A COBAS 8000 COBAS C701 MODULE. INITIAL RESULT: 14.2 MMOL/L. THE CUSTOMER QUESTIONED THE INITIAL RESULT AS IT DID NOT MATCH THE PATIENT'S CLINICAL HISTORY. NO QUESTIONABLE RESULT WAS REPORTED OUTSIDE THE LABORATORY AND THE SAMPLE WAS REPEATED. REPEAT RESULT: 5.31 MMOL/L. THE REPEAT RESULT WAS DEEMED TO BE CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    914679 COBAS 8000 C 701 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown