BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL D MODULE

    MDR report key: 1244870 · Received November 20, 2008

    Report

    Report Number
    1823260-2008-08611
    Event Type
    Malfunction
    Date Received
    November 20, 2008
    Date of Event
    November 8, 2008
    Report Date
    November 20, 2008
    Manufacturer
    HITACHI HIGH TECH. CORP.
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER RECEIVED DISCREPANT CALCIUM VALUES FOR FIFTY FIVE PATIENT SAMPLES. THE SAMPLES WERE INITIALLY RUN ON EITHER THIS ANALYZER OR D MODULE. IT IS UNK WHICH SAMPLES RESULTS CAME FROM EACH ANALYZER. ALL SAMPLES WERE REPEATED ON A DIFFERENT ANALYZER. THE FOLLOWING FORTY TWO EXAMPLES WERE PROVIDED. UNITS = MG/DL. SAMPLE 1: INITIAL 7.9/REPEAT 8.7. SAMPLE 2: 9.1/9.9. SAMPLE 3: 8.6/9.4. SAMPLE 4: 8.6/9.4. SAMPLE 5: 8.8/9.7. SAMPLE 6: 8.2/9.0. SAMPLE 7: 8.3/9.3. SAMPLE 8: 8.3/9.2. SAMPLE 9: 8.4/9.3. SAMPLE 10: 8.4/9.3. SAMPLE 11: 8.5/9.5. SAMPLE 12: 8.5/9.4. SAMPLE 13: 8.2/9.2. SAMPLE 14: 8.0/8.9. SAMPLE 15: 8.6/9.6. SAMPLE 16: 8.3/9.1. SAMPLE 17: 8.6/9.5. SAMPLE 18: 8.5/9.6. SAMPLE 19: 7.6/8/6. SAMPLE 20: 8.4/9.4. SAMPLE 21: 9.6/10.7. SAMPLE 22: 8.6/9.5. SAMPLE 23: 8.1/9.3. SAMPLE 24: 8.5/9.5. SAMPLE 25: 7.7/8.7. SAMPLE 26: 8.5/9.7. SAMPLE 27: 8.2/9.3. SAMPLE 28: 7.9/9.0. SAMPLE 29: 8.5/9.5. SAMPLE 30: 8.2/9.2. SAMPLE 31: 8.5/9.6. SAMPLE 32: 8.3/9.3. SAMPLE 33: 8.2/9.2. SAMPLE 34: 8.3/9.3. SAMPLE 35: 8.2/9.2. SAMPLE 36: 8.0/9.1. SAMPLE 37: 8.3/9.3. SAMPLE 38: 8.6/9.8. SAMPLE 39: 8.2/9.3. SAMPLE 40: 8.4/9.5. SAMPLE 41: 8.6/9.7. SAMPLE 42: 8.5/9.4. THE INITIAL PT RESULTS WERE NOT REPORTED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE CAUSE FOR BOTH D MODULE ANALYZERS TO BE POTENTIAL BUILDUP IN THE CALCIUM REAGENT LINES AND DIRTY SAMPLES PROBES. FOR BOTH ANALYZERS, THE CALCIUM REAGENT LINES WERE FLUSHED WITH .5 HCI, SAMPLE PROBES WERE CLEANED AND STYLETED, AND REAGENT LINES WERE PURGED AND PRIMED. IT WAS ALSO OBSERVED THAT CALIBRATORS USED THAT SAME DAY HAD BEEN STORED REFRIGERATED FOR LONGER THAN STATED PACKAGE INSERT STABILITY DURATION. PERFORMANCE TESTS WERE PERFORMED AND WITHIN SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANALYTICAL D MODULE CLINICAL CHEMISTRY ANALYZER - JJE JJE HITACHI HIGH TECH. CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK