BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 1616396 · Received February 26, 2010

    Report

    Report Number
    1823260-2010-01265
    Event Type
    Malfunction
    Date Received
    February 26, 2010
    Date of Event
    February 4, 2010
    Report Date
    February 26, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN IF INITIAL REPORTER SENT REPORT TO FDA.

    Description of Event or Problem · 1

    CUSTOMER HAD AN ISSUE WITH SODIUM PRECISION AND SHE REPEATED SIX PATIENT SAMPLES MULTIPLE TIMES. RESULTS FOR TWO PATIENTS WERE DISCREPANT: PATIENT 1, SODIUM RESULTS, 132, 126, 128, 128, 126, AND 129 MMOL/L. (ALL RESULTS WERE ACCOMPANIED BY A < REFERENCE RANGE DATA FLAG). THEY REPORTED 128 MMOL/L FOR THIS SAMPLE. PATIENT 2, SODIUM RESULTS, 139, 133, 133, 133, AND 133 MMOL/L. (ALL 133 RESULTS WERE ACCOMPANIED BY A < REFERENCE RANGE DATA FLAG). THIS SAMPLE HAD BEEN TESTED THE DAY BEFORE AND RECOVERED 136 MMOL/L WHICH WAS REPORTED. CUSTOMER DOES NOT KNOW IF PATIENTS WERE TREATED BASED ON REPORTED RESULTS. NO ADVERSE EVENTS WERE REPORTED. LOT NUMBER OF SODIUM ELECTRODE IS UNKNOWN. THE FIELD SERVICE DETERMINED A BAD SODIUM ELECTRODE WAS THE CAUSE OF THE DISCREPANCIES. HE REPLACED THE SODIUM AND REFERENCE ELECTRODES. CUSTOMER RAN CONTROLS WHICH WERE ACCEPTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS INTEGRA 800 CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1