BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 18371415 · Received December 21, 2023

    Report

    Report Number
    1823260-2023-04151
    Event Type
    Malfunction
    Date Received
    December 21, 2023
    Date of Event
    November 23, 2023
    Report Date
    January 4, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630924707
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS PROVIDED THAT THE AMMONIA REAGENT WAS NOT A ROCHE PRODUCT BUT WAS MANUFACTURED BY A THIRD PARTY (RANDOX). INVESTIGATION OF THE C501 ANALYZER DID NOT IDENTIFY ANY HARDWARE ISSUES. A PRECISION CHECK WAS PERFORMED AND WAS WITHIN SPECIFICATIONS. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Additional Manufacturer Narrative · 0

    THE REAGENT LOT NUMBER AND EXPIRATION DATE WERE REQUESTED BUT WERE NOT PROVIDED. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE AMMONIA (NH3L2) RESULTS FROM THE COBAS 6000 C501 MODULE. THE INITIAL RESULT WAS 313 UMOL/L. A NEW SAMPLE WAS COLLECTED AND THE RESULT WAS 42 UMOL/L. ON (B)(6) 2023, THE ORIGINAL SAMPLE WAS REPEATED AND THE RESULT WAS 55 UMOL/L. THIS RESULT WAS BELIEVED CORRECT AND WAS REPORTED OUTSIDE OF THE LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298003 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS 04015630924707

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown