BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 1873713 · Received October 19, 2010

    Report

    Report Number
    1823260-2010-06189
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    September 30, 2010
    Report Date
    October 19, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE RESULTS FOR THREE PATIENT SAMPLES. OF THE DATA PROVIDED, RESULTS FOR TWO OF THE SAMPLES WERE DISCREPANT. PATIENT SAMPLE 1 INITIAL ALT (ALANINE AMINOTRANSFERASE) RESULT WAS -6 U/L WITH A DATA FLAG. THE SAMPLE WAS AUTOMATICALLY REPEATED AND THE RESULT WAS 79 U/L. THE SAMPLE WAS THEN REPEATED ON P MODULE SERIAL NUMBER (B)(4) AND THE RESULT WAS 38 U/L. PATIENT SAMPLE 2 WAS FROM A (B)(6) MALE. THE INITIAL AST (ASPARTATE AMINOTRANSFERASE) RESULT WAS -67 U/L WITH A DATA FLAG. THE SAMPLE WAS AUTOMATICALLY REPEATED AND THE RESULT WAS 87 U/L. THE SAMPLE WAS THEN REPEATED ON P MODULE SERIAL NUMBER (B)(4) AND THE RESULT WAS 14 U/L. THE PATIENTS WERE NOT AFFECTED AS THE INITIAL RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY. THE RESULTS FROM P MODULE SERIAL NUMBER (B)(4) WERE BELIEVED TO BE CORRECT AND THOSE WERE REPORTED OUTSIDE THE LABORATORY. THE ALT AND AST REAGENT LOT NUMBERS WERE NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE SAMPLE PROBE WAS HITTING THE SIDE OF THE TEST TUBES CAUSING A FLUIDIC FAILURE OF THE SAMPLE ASPIRATION. HE ADJUSTED THE SAMPLE PROBE TO ALL SAMPLE POINTS. TO VERIFY THE ANALYZER OPERATION, HE PERFORMED QUALITY CONTROL AND PRECISION TESTING WITH ALL RESULTS WITHIN THE USER'S SPECIFICATIONS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 026 YR