BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 3233955 · Received July 18, 2013

    Report

    Report Number
    1823260-2013-04347
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    July 4, 2013
    Report Date
    July 18, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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, CREATININE, BICARBONATE, AND ION SELECTIVE ELECTRODE CHLORIDE, SODIUM, AND POTASSIUM RESULTS ON THEIR C501 ANALYZER. THE CUSTOMER PROVIDED DATA FOR ONE DISCREPANT GLUCOSE RESULT THAT WAS REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER ALLEGED THAT ON (B)(6) 2013 DURING THE NIGHT SHIFT, THEY HAD SEVERAL SAMPLES THAT GAVE LOW RESULTS. THE NIGHT SHIFT DID SOMETHING TO THE ANALYZER, BUT THE CUSTOMER DID NOT KNOW WHAT. THEY THEN PERFORMED QUALITY CONTROL WHICH WAS FINE AND MASKED THE MODULE. THE CUSTOMER STATED THAT ON THE MORNING OF THE EVENT, QUALITY CONTROL WAS FINE AND A PRECISION CHECK OF A SAMPLE LOOKED GREAT. THE CUSTOMER STARTED RUNNING PATIENT SAMPLES. AFTER AN HOUR, ONE RACK OF SAMPLES GAVE LOW RESULTS. THE AUTO-REPEAT RESULTS WERE ALSO LOW. THE CUSTOMER REPEATED THE SAMPLES ON ANOTHER COBAS 6000 ANALYZER, AND THE RESULTS WERE HIGHER. THE CUSTOMER STATED THE SAMPLES LOOKED FINE AND DID NOT CONTAIN ANY CLOTS. THE PATIENT'S INITIAL GLUCOSE RESULT WAS 42 MG/DL ACCOMPANIED BY A DATA FLAG. THE CUSTOMER STATED THE REPEAT RESULT WAS "80 SOMETHING" MG/DL. THE REPEAT RESULTS WERE CONSIDERED CORRECT AND ISSUED AS CORRECTED REPORTS. THE CUSTOMER FELT THE RESULTS WERE CORRECTED BEFORE ANY TREATMENTS WOULD HAVE BEEN CHANGED. THERE WERE NO ADVERSE EVENTS. THE GLUCOSE REAGENT LOT NUMBER WAS 67526101 AND THE EXPIRATION DATE WAS 04/30/2014. THE FIELD SERVICE REPRESENTATIVE FOUND A FAULTY SAMPLE PROBE. HE REPLACED THE SAMPLE PROBE. THE CUSTOMER PERFORMED CALIBRATION, QUALITY CONTROL, AND A PRECISION CHECK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334984 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1