BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL D MODULE

    MDR report key: 1873347 · Received October 19, 2010

    Report

    Report Number
    1823260-2010-06185
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    September 28, 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
    HI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED QUESTIONABLE CALCIUM RESULTS ON AN UNKNOWN NUMBER OF PATIENT SAMPLES WHEN TESTING WAS PERFORMED ON THE MODULAR ANALYTICS D MODULE. THE CUSTOMER STATED THAT 150 CORRECTED REPORTS WERE SENT, BUT WOULD ONLY PROVIDE DATA FOR ONE INSTANCE. THE INITIAL CALCIUM RESULT WAS 13.1 MG/DL. THE TEST WAS REPEATED ON A SECOND D MODULE, SERIAL NUMBER (B)(4), WITH A RESULT OF 10.9 MG/DL. THE CUSTOMER DID NOT KNOW IF ANY OF THE PATIENTS WERE AFFECTED BY THE EVENT AND DECLINED TO FOLLOW UP FOR THAT INFORMATION. THE CALCIUM REAGENT LOT NUMBER WAS 62783101. THE FIELD SERVICE REPRESENTATIVE DETERMINED THAT THE EVENT WAS CAUSED BY CONTAMINATION IN THE REACTION CELLS. HE PERFORMED REAGENT FLOWPATH WASH, CLEANED THE REACTION CELLS, AND CALIBRATED CALCIUM. QUALITY CONTROL TESTS WERE PERFORMED AND PASSED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1