BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 3893633 · Received June 25, 2014

    Report

    Report Number
    1823260-2014-04643
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    June 13, 2014
    Report Date
    July 8, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    A ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT PROVIDED. THE ISSUES THE FIELD SERVICE REPRESENTATIVE FOUND WOULD CAUSE CARRY OVER EFFECTS AND HIGHER RESULTS; NOT THE LOWER RESULTS SEEN IN THIS EVENT. THE ANALYZER WAS CONFIRMED TO BE RUNNING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY WERE RECEIVING QUESTIONABLY LOW GLUCOSE HK GEN.3, BUN, LACTATE, DIRECT BILIRUBIN, AND BICARBONATE RESULTS ON THEIR C501 ANALYZER INTERMITTENTLY THROUGHOUT THE DAY. THE CUSTOMER PROVIDED DATA FOR FOUR RESULTS, OF WHICH THERE WAS ONE DISCREPANT GLUCOSE RESULT. THE PATIENT'S INITIAL GLUCOSE RESULT WAS 2.4 MG/DL AND IT WAS REPORTED OUTSIDE THE LABORATORY. THE SAMPLE WAS REPEATED AND THE RESULT WAS 117.8 MG/DL. THERE WERE NO ADVERSE EVENTS. THE GLUCOSE REAGENT LOT NUMBER WAS 68809801 AND THE EXPIRATION DATE WAS 11/30/2014. THE FIELD SERVICE REPRESENTATIVE FOUND AN ISSUE WITH THE GEAR PUMP PRESSURE AND THAT THE SAMPLE PROBE EXTERNAL WASH WAS SET TOO LOW. HE ADJUSTED THE GEAR PUMP PRESSURE AND THE EXTERNAL PROBE WASH. HE PERFORMED TWO PRECISION CHECKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370470 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1