BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 1083167 · Received July 24, 2008

    Report

    Report Number
    1823260-2008-05757
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    July 14, 2008
    Report Date
    July 24, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    TWO PATIENT SAMPLES WITH DISCREPANT RESULTS. SAMPLE 1: INITIAL BICARBONATE RESULT 0.7 MMOL/L, REPEAT 23.7 MMOL/L; INITIAL LIPASE RESULT 0 U/L, REPEAT 15 U/L; INITIAL AMYLASE RESULT 35 U/L, REPEAT 54 U/L. SAMPLE 2: INITIAL BICARBONATE RESULT 1.3 MMOL/L, REPEAT 21.7 MMOL/L. ERRONEOUS RESULTS WERE NOT REPORTED. THE FIELD SERVICE REPRESENTATIVE DETERMINED ISSUE TO BE R1 PROBE AND PERFORMED VERTICAL ADJUSTMENT OF PROBE. PERFORMANCE TESTS WERE PERFORMED AND WITHIN SPECIFICATIONS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK