BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTAL PROTEIN GEN.2

    MDR report key: 2132768 · Received June 17, 2011

    Report

    Report Number
    1823260-2011-03324
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 31, 2011
    Report Date
    June 17, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CEK
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL ASSAYS INVOLVED IN THIS EVENT ARE REPORTED ON THE MEDWATCH FORMS PATIENT IDENTIFIERS (B)(6).

    Description of Event or Problem · 1

    THE USER EXPERIENCED CALIBRATION ERRORS AND FLAGGED RESULTS FOR PATIENT SAMPLES FROM THE INTEGRA 800 ANALYZER SERIAL NUMBER (B)(4). THE USER REPEATED TESTING OF THE PATIENT SAMPLES ON THE OTHER INTEGRA 800 ANALYZER SERIAL NUMBER (B)(4). OF THE DATA PROVIDED, THE TOTAL PROTEIN RESULTS FOR TWO PATIENT SAMPLES WERE DISCREPANT AND REPORTED OUTSIDE THE LABORATORY. PATIENT SAMPLE 1 INITIAL RESULT WAS 8.5 G/DL AND THE REPEAT RESULT WAS 7.0 G/DL. PATIENT SAMPLE 2 WAS FROM A FEMALE PATIENT BORN ON (B)(6). THE INITIAL RESULT WAS 9.1 G/DL AND THE REPEAT RESULT WAS 7.5 G/DL. THE PATIENTS WERE NOT ADVERSELY AFFECTED. UPON EVALUATION OF THE ANALYZER, THE FIELD SERVICE REPRESENTATIVE DETERMINED THERE WAS A DEFECTIVE AND DISCONNECTED LEVEL SENSE CABLE. HE REPLACED THE LIQUID LEVEL SENSE CABLE, WORN ROPES AND A BENT PROBE. HE CONNECTED THE VALVE CABLE ABOVE THE TRANSFER ARM TO THE REAGENT MODULE BODY. TO VERIFY THE ANALYZER OPERATION, HE RAN PERFORMANCE TESTING AND THE USER RAN AND VERIFIED QUALITY CONTROL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTAL PROTEIN GEN.2 BIURET (COLORIMETRIC), TOTAL PROTEIN CEK ROCHE DIAGNOSTICS NA 63870401

    Patients

    Seq Age Sex Outcome Treatment
    1 045 YR