BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C (501) MODULE

    MDR report key: 6332614 · Received February 15, 2017

    Report

    Report Number
    1823260-2017-00334
    Event Type
    Malfunction
    Date Received
    February 15, 2017
    Date of Event
    January 27, 2017
    Report Date
    February 15, 2017
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A QUESTIONABLE LOW GLUC3 GLUCOSE HK RESULT FOR ONE PATIENT SAMPLE. THE RESULT FROM A SECOND SAMPLE DRAWN FOR A GLUCOSE TOLERANCE TEST WAS 3.5 MMOL/L. THE SAMPLE WAS REPEATED DUE TO SOME TUBE PROBLEMS IN THE LABORATORY. THE REPEAT RESULT FOR THE SAMPLE WAS 5.0 MMOL/L TWICE. THE ERRONEOUS RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE REAGENT LOT NUMBER WAS 203181. THE EXPIRATION DATE WAS REQUESTED BUT WAS NOT PROVIDED. REVIEW OF THE PROVIDED REACTION MONITOR DID NOT FIND A CAUSE. MOST LIKELY, A TOO SMALL SAMPLE VOLUME WAS TRANSFERRED INTO THE MEASURING CELL. AS THE REPEAT RESULTS WERE STABLE, A GENERAL REAGENT/APPLICATION ISSUE COULD BE RULED OUT. A SAMPLE SPECIFIC PROBLEM WAS EXCLUDED AS THE REPEAT RESULTS WERE ACCEPTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116879 COBAS 6000 C (501) MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS C501 NA

    Patients

    Seq Age Sex Outcome Treatment
    1