BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 1873344 · Received October 19, 2010

    Report

    Report Number
    1823260-2010-06183
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    September 25, 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
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED A DISCREPANT IGG RESULT WHEN TESTING WAS PERFORMED ON THE MODULAR ANALYTICS P MODULE. THE INITIAL IGG TEST YIELDED A RESULT OF 245 MG/DL, WHICH WAS REPORTED OUTSIDE THE LABORATORY. THE PHYSICIAN QUESTIONED THE RESULT. TESTING WAS REPEATED ON (B)(6) 2010 WITH A RESULT OF 1286 MG/DL. THE CUSTOMER STATED THAT TESTING WAS ALSO REPEATED BY A GEL SEPARATION METHOD WITH A RESULT OF > 1000 MG/DL. THE CUSTOMER STATED THAT THE PATIENT WAS NOT AFFECTED BY THE EVENT. THE IGG REAGENT LOT NUMBER WAS 62219601. THE FIELD SERVICE REPRESENTATIVE DETERMINED THAT THE EVENT WAS DUE TO A REAGENT PROBE POSITIONED TOO CLOSE TO THE EDGE OF A REACTION CELL, CAUSING REAGENT TO HIT THE TOP OF THE REACTION CELL AND SPLATTER INTO AN ADJACENT CELL. HE ADJUSTED THE PROBE AND CLEANED THE REACTION CELL TOPS. PATIENTS AND QUALITY CONTROLS WERE RUN SUCCESSFULLY.

    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