BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 400

    MDR report key: 1883991 · Received October 27, 2010

    Report

    Report Number
    1823260-2010-06380
    Event Type
    Malfunction
    Date Received
    October 27, 2010
    Date of Event
    October 7, 2010
    Report Date
    October 27, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE CALCIUM RESULTS FOR PATIENT SAMPLES. OF THE DATA PROVIDED, THE RESULTS FOR 10 OF THE PATIENT SAMPLES WERE DISCREPANT. ALL RESULTS ARE IN MG/DL. THE RESULTS LISTED BELOW ARE THE RESULT WITH REAGENT LOT 626019, THE RESULT WITH REAGENT LOT 628028, THEN THE RESULT FROM A REFERENCE LAB. PATIENT SAMPLE 1 RESULTS WERE 10.8, 10.4 AND 9.5. PATIENT SAMPLE 2 RESULTS WERE 11.3, 11.8 AND 10.9. PATIENT SAMPLE 3 RESULTS WERE 11.4, 11.0 AND 10.1. PATIENT SAMPLE 4 RESULTS WERE 10.7, 11.7, 11.0 AND 10.1. PATIENT SAMPLE 5 RESULTS WERE 11.0, 10.7 AND 9.9. PATIENT SAMPLE 6 RESULTS WERE 11.7, 10.9 AND 10.4 PATIENT SAMPLE 7 RESULTS WERE 11.4, 10.2 AND 10.3. PATIENT SAMPLE 8 RESULTS WERE 11.1, 10.3 AND 9.7. PATIENT SAMPLE 9 RESULTS WERE 10.9, 10.1 AND 9.6. PATIENT SAMPLE 10 RESULTS WERE 10.9, 10.1 AND 9.6. THE PATIENTS WERE NOT ADVERSELY AFFECTED AS THE RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY. THE FIELD SERVICE REPRESENTATIVE FOUND THE EXTERNAL AND INTERNAL WATER FILTERS WERE DIRTY. HE REPLACED THE WATER FILTERS AND THE INLET FILTER. TO VERIFY THE ANALYZER OPERATION, HE RAN PERFORMANCE AND PRECISION TESTING WITH GOOD RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS INTEGRA 400 CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1