BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 1831286 · Received September 10, 2010

    Report

    Report Number
    1823260-2010-05371
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Date of Event
    August 24, 2010
    Report Date
    September 10, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE RESULTS FOR MAGNESIUM, PHOSPHORUS, TOTAL PROTEIN, ALBUMIN AND PREALBUMIN. OF THE DATA PROVIDED, THE MAGNESIUM RESULT FOR ONE PATIENT SAMPLE WAS DISCREPANT. THE ORIGINAL RESULT WAS 2.6 MG/DL WHICH HAD A DELTA CHECK IN THE LIS SYSTEM. THE USER REPEATED THE SAMPLE ON ANOTHER P MODULE AND THE RESULT WAS 1.4 MG/DL. THE USER STATED THE PATIENTS WERE NOT AFFECTED AS THE ORIGINAL RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY. THE MAGNESIUM REAGENT LOT NUMBERS WERE 62161801 AND 61952001. THE FIELD SERVICE REPRESENTATIVE DETERMINED THERE WERE DEFECTIVE REAGENT PROBES AND THE USER HAD REPLACED THE REAGENT PROBES PRIOR TO HIS ARRIVAL ONSITE. HE PERFORMED A CELL BLANK AND PHOTOMETER CHECK WITH NO ERRORS. TO VERIFY THE ANALYZER OPERATION, THE USER RAN MAGNESIUM QUALITY CONTROL WITH NO ERRORS.

    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