BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 2241804 · Received September 9, 2011

    Report

    Report Number
    1823260-2011-04820
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    August 22, 2011
    Report Date
    September 9, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE USER RECEIVED HIGH PHOSPHORUS RESULTS FOR QUALITY CONTROL AND TWO PATIENT SAMPLES. DATA WAS ONLY PROVIDED FOR ONE PATIENT SAMPLE. THE INITIAL RESULT WAS 7.9 MG/DL AND WAS REPORTED OUTSIDE THE LABORATORY. THE SAMPLE WAS REPEATED AND THE RESULT WAS 4.4 MG/DL. THE INITIAL RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE USER REFUSED TO PROVIDE INFORMATION TO DETERMINE IF THE PATIENT WAS ADVERSELY AFFECTED. THE PHOSPHORUS REAGENT LOT NUMBER WAS NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE PROBES WERE OUT OF ALIGNMENT AND WERE DUE TO BE REPLACED. HE REPLACED ALL THE PROBES, PERFORMED ALL ALIGNMENTS, REPLACED THE REACTION CELLS AND RAN A CELL BLANK WITH NO ISSUES. HE ALSO REPLACED THE GEAR PUMP AS A PRECAUTION. TO VERIFY THE ANALYZER OPERATION, THE CUSTOMER RAN CALIBRATION AND QUALITY CONTROL WITH RESULTS WITHIN THE SPECIFIED LIMITS.

    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