BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 1631067 · Received March 16, 2010

    Report

    Report Number
    1823260-2010-01619
    Event Type
    Malfunction
    Date Received
    March 16, 2010
    Date of Event
    February 18, 2010
    Report Date
    March 16, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JFY
    PMA / PMN Number
    K953239
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    THE USER EXPERIENCED CREATININE IMPRECISION ON THE P MODULE ANALYZER AND PROVIDED A DISCREPANT RESULT FOR ONE PATIENT SAMPLE. THE INITIAL RESULT WAS 0.49 MG/DL AND WAS REPORTED. THE DOCTOR CAUGHT THE DISCREPANCY AND ASKED THAT THE SAMPLE BE RERUN. THE PATIENT WAS NOT TREATED BASED ON THE ORIGINAL RESULT. THE REPEAT RESULT ON THE SAME ANALYZER WAS 1.56 MG/DL AND ON ANOTHER P MODULE WAS 1.53 MG/DL. THE CREATININE R1 REAGENT LOT NUMBER WAS 61884401 AND THE CREATININE R2 REAGENT LOT NUMBER WAS 61801801. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE GEAR PUMP UNIT WAS LEAKING AND REPLACED IT. TO VERIFY THE ANALYZER OPERATION, HE RAN PRECISION TESTING WITH RESULTS WITHIN RANGE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1