BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL D MODULE

    MDR report key: 1680682 · Received May 12, 2010

    Report

    Report Number
    1823260-2010-02853
    Event Type
    Malfunction
    Date Received
    May 12, 2010
    Date of Event
    April 20, 2010
    Report Date
    May 12, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    USER RECEIVED ERRATIC ALBUMIN RESULTS FOR ABOUT 63 PATIENTS SAMPLES AND DETERMINED THE TOTAL PROTEIN LINE OF THE ANALYZER WAS DRIPPING. USER PROVIDED RESULTS FOR 107 PATIENT SAMPLES, 23 WERE DISCREPANT. USER DID NOT PROVIDE THE ANALYZER OR METHOD USED FOR REPEAT TESTING. SAMPLE 1, INITIAL 9.0; REPEAT 4.5 G/DL. SAMPLE 2, INITIAL 8.4; REPEAT 4.3 G/DL. SAMPLE 3, INITIAL 7.9; REPEAT 4.8 G/DL. SAMPLE 4, INITIAL 9.0; REPEAT 4.8 G/DL. SAMPLE 5, INITIAL 10.9; REPEAT 4.0 G/DL. SAMPLE 6, INITIAL 8.3; REPEAT 4.3 G/DL. SAMPLE 7, INITIAL 11.1; REPEAT 4.2 G/DL. SAMPLE 8, INITIAL 11.9; REPEAT 4.6 G/DL. SAMPLE 9, INITIAL 6.9; REPEAT 4.0 G/DL. SAMPLE 10, INITIAL 7.6; REPEAT 3.7 G/DL. SAMPLE 11, INITIAL 11.0; REPEAT 4.3 G/DL. SAMPLE 12, INITIAL 11.0; REPEAT 3.9 G/DL. SAMPLE 13, INITIAL 9.4; REPEAT 4.4 G/DL. SAMPLE 14, INITIAL 5.6; REPEAT 3.7 G/DL. SAMPLE 15, INITIAL 9.4; REPEAT 4.6 G/DL. SAMPLE 16, INITIAL 11.0; REPEAT 3.9 G/DL. SAMPLE 17, INITIAL 11.4; REPEAT 4.1 G/DL. SAMPLE 18, INITIAL 12.2; REPEAT 4.5 G/DL. SAMPLE 19, INITIAL 8.8; REPEAT 4.0 G/DL. SAMPLE 20, INITIAL 11.5; REPEAT 4.1 G/DL. SAMPLE 21, INITIAL 12.4; REPEAT 4.4 G/DL. SAMPLE 22, INITIAL 12.6; REPEAT 5.0 G/DL. SAMPLE 23, INITIAL 8.7; REPEAT 4.1 G/DL. INITIAL RESULTS WERE NOT REPORTED. ALBUMIN REAGENT LOT NUMBER - R1 61389901, R2 61635901. THE FIELD SERVICE REPRESENTATIVE FOUND AIR IN THE TOTAL PROTEIN LINE. THE TOTAL PROTEIN REAGENT LINE WAS DRIPPING ONTO THE REACTION CELLS AND IN THE ALBUMIN CELLS. HE RINSED AND PRIMED ALL REAGENTS AND RAN PRECISION. THE CUSTOMER RAN CALIBRATION AND CONTROLS GIVING RESULTS WITHIN SPECIFICATION FOR ALL ASSAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANALYTICAL D MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1