BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 2925173 · Received January 22, 2013

    Report

    Report Number
    1823260-2013-00384
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    January 3, 2013
    Report Date
    January 22, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO INFORMATION WAS PROVIDED ON THE SPECIFIC PART NUMBER INVOLVED IN THIS EVENT. THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A QUESTIONABLE CREATININE JAFFE GENERATION 2 RESULT FOR ONE PATIENT SAMPLE. THE INITIAL RESULT WAS 7.87 MG/DL AND WAS REPORTED OUTSIDE THE LABORATORY. THE PHYSICIAN DID NOT AGREE WITH THIS RESULT AND THE SAMPLE WAS REPEATED. ON (B)(6) 2013, THE RESULT FROM THE SAME SAMPLE WAS 3.30 MG/DL ON A DIFFERENT COBAS C501 ANALYZER AND 3.54 MG/DL ON THE ORIGINAL ANALYZER. THE PATIENT HAD A CT FOR A URINARY STONE AND WAS NOT ADVERSELY AFFECTED. THE CREATININE REAGENT LOT NUMBER WAS 671597 WITH AN EXPIRATION DATE OF 07/30/2014. THE INVESTIGATION COULD NOT DETERMINE A SPECIFIC ROOT CAUSE DUE TO THE LIMITED INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29339 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 062 YR