BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 1902097 · Received November 18, 2010

    Report

    Report Number
    1823260-2010-06807
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    November 4, 2010
    Report Date
    November 18, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE RESULTS FOR MAGNESIUM, TOTAL BILIRUBIN SPECIAL, AND BILIRUBIN DIRECT. THE SAMPLES WERE REPEATED ON THE OTHER INTEGRA 800 AT THE SITE. OF THE DATA FOR FIVE SAMPLES THAT WAS PROVIDED, THE MAGNESIUM RESULTS FOR TWO SAMPLES WERE DISCREPANT. PATIENT SAMPLE 1 INITIAL RESULT WAS 0.7 MMOL/L AND THE REPEAT RESULTS WERE 1.5 AND 1.6 MMOL/L. PATIENT SAMPLE 2 INITIAL RESULT WAS 0.4 MMOL/L AND THE REPEAT RESULT WAS 1.3 MMOL/L. THE USER THOUGHT SOME OF THE RESULTS MAY HAVE BEEN FLAGGED BUT WAS NOT SURE. THE INCORRECT RESULTS WERE NOT REPORTED. THE PATIENTS WERE NOT AFFECTED. THE MAGNESIUM REAGENT LOT NUMBER WAS 63070501. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE WORKSTATIONS WERE NOT ADJUSTED TO SPECIFICATION. HE REMOVED THE WORKSTATION AND CLEANED AND LUBED IT. TO VERIFY THE ANALYZER OPERATION, HE RAN PRECISION TESTING AND PERFORMANCE TESTS WITH NO ISSUES. HE NOTED THERE WERE NO ISSUES WITH TOTAL BILIRUBIN SPECIAL AND BILIRUBIN DIRECT WHEN HE ARRIVED AT THE SITE. HE STATED IT WAS POSSIBLE THAT THE ISSUE WITH THESE ASSAYS WAS CORRECTED BY THE USER WHEN THEY CHANGED THE PROBES.

    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