BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501MODULE

    MDR report key: 1914937 · Received December 6, 2010

    Report

    Report Number
    1823260-2010-07155
    Event Type
    Malfunction
    Date Received
    December 6, 2010
    Date of Event
    October 21, 2010
    Report Date
    December 6, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CFR
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE RESULTS FOR GLUCOSE HK GENERATION 3 (GLUC3) ON THE COBAS 6000 C501 ANALYZER FOR ONE PATIENT SAMPLE. THE INITIAL RESULT WAS 135 MG/DL. THIS RESULT WAS QUESTIONED AS THE PATIENT IS NON-DIABETIC. THE SAMPLE WAS REPEATED WHICH YIELDED A RESULT OF 102 MG/DL. THE PATIENT WAS NOT AFFECTED AS THE INITIAL RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY. THE REAGENT LOT NUMBER FOR GLUC3 WAS 630353.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS 6000 C501MODULE CLINICAL CHEMISTRY ANALYZER CFR ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1