BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA ALKALINE PHOSPHATASE

    MDR report key: 297158 · Received September 18, 2000

    Report

    Report Number
    1823260-2000-00194
    Event Type
    Malfunction
    Date Received
    September 18, 2000
    Date of Event
    March 14, 2000
    Report Date
    September 12, 2000
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER LOADED AND RAN ONE REAGENT CASSETTE ON ONE ANALYZER. THE CUSTOMER THEN TOOK THIS REAGENT CASSETTE OFF OF THIS ANALYZER AND LOADED ONTO ANOTHER ANALYZER AND RAN SEVERAL PT SAMPLES. THE ANALYZER RECOGNIZED THIS CASSETTE AS A NEW REAGENT CASSETTE. 7 PATIENT SAMPLES RECOVERED FALSELY ZERO. NO RESULTS WERE REPORTED FOR PT TREATMENT. SAMPLES WERE RETURN. THESE VALUES WERE REPORTED FOR PT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS INTEGRA ALKALINE PHOSPHATASE LABORATORY CLINICAL CHEMISTRY CASSETTE CJE ROCHE DIAGNOSTICS NA 61013501

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN