BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 1030600 · Received April 16, 2008

    Report

    Report Number
    1823260-2008-03283
    Event Type
    Malfunction
    Date Received
    April 16, 2008
    Date of Event
    March 25, 2008
    Report Date
    April 16, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    ACCOUNT EXPERIENCING DISCREPANT CREATININE RESULTS FOR 2 PATIENT SAMPLES. PATIENT 1, INITIAL RESULT GAVE 2.96 MG/DL; REPEAT GAVE 1.16 MG/DL. ERRONEOUS RESULT REPORTED ONLY FOR PATIENT 1. PATIENT NOT ADVERSELY AFFECTED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE CAUSE FOR THE DISCREPANCIES TO BE DUE THE SAMPLE PROBE BLINDING IN SAMPLE PROBE ARM, AND CLEANED SAMPLE PROBE AND PROBE HOLDER. PERFORMANCE TESTS WERE PERFORMED AND WITHIN SPECIFICATION.

    Description of Event or Problem · 2

    ACCOUNT EXPERIENCING DISCREPANT CREATININE RESULTS FOR 2 PATIENT SAMPLES. PATIENT 2: OCCURRED IN 2008, INITIAL RESULT GAVE 0.62 MG/DL; REPEAT GAVE <0.30 MG/DL. ERRONEOUS RESULT REPORTED ONLY FOR PATIENT 1. PATIENT NOT ADVERSELY AFFECTED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE CAUSE FOR THE DISCREPANCIES TO BE DUE THE SAMPLE PROBE BLINDING IN SAMPLE PROBE ARM, AND CLEANED SAMPLE PROBE AND PROBE HOLDER. PERFORMANCE TESTS WERE PERFORMED AND WITHIN SPECIFICATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR
    2 9 DA