BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 3222622 · Received July 12, 2013

    Report

    Report Number
    1823260-2013-04222
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    July 1, 2013
    Report Date
    July 11, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED QUESTIONABLE GLUCOSE HK GEN.3 (GLUC) AND CREATININE RESULTS ON THEIR C501 ANALYZER FOR ONE PATIENT. THE CUSTOMER PROVIDED DATA FOR ONE DISCREPANT GLUC RESULT THAT WAS REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER STATED THAT ALL THE OTHER ASSAYS TESTED FOR THIS SAMPLE WERE OK. ALL TESTING WAS PERFORMED ON THE SAME ANALYZER. THE PATIENT'S INITIAL GLUC RESULT WAS 21 MG/DL. THE REPEAT RESULT WAS 104 MG/DL. THE REPEAT RESULT WAS CONSIDERED CORRECT. THE PATIENT WAS NOT ADVERSELY AFFECTED BY THIS EVENT. THE GLUC REAGENT LOT NUMBER WAS 67526101 AND THE EXPIRATION DATE WAS 04/30/2014. IT WAS NOTED THE PATIENT'S SAMPLE WAS TESTED IN A MICRO CUP. THE SAMPLE WAS PROCESSED WITH A BAR CODE AND WAS NOT PROGRAMMED AS A MICRO CUP. THE FIELD SERVICE REPRESENTATIVE FOUND A DAMAGED SAMPLE PROBE. HE REPLACED THE DAMAGED SAMPLE PROBE. HE VERIFIED THE SAMPLE PROBE ALIGNMENT IN THE SERVICE SOFTWARE. THE CUSTOMER PERFORMED A PRECISION TEST WITH RESULTS MEETING SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324424 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 058 YR