BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 1345244 · Received February 3, 2009

    Report

    Report Number
    1823260-2009-00835
    Event Type
    Malfunction
    Date Received
    February 3, 2009
    Date of Event
    January 11, 2009
    Report Date
    February 3, 2009
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CUSTOMER RECEIVED THREE PATIENT SAMPLES REPORTED TO HAVE WRONG RESULTS. EXACT DATE OF TESTING WAS NOT PROVIDED FOR THESE PATIENT SAMPLES. ONE EXAMPLE HAS BEEN PROVIDED WHICH GAVE DISCREPANT RESULTS FOR TOTAL BILIRUBIN WHEN COMPARED TO ANOTHER METHODOLOGY. INITIAL TOTAL BILIRUBIN GAVE 8.5 UMOL/L; REPEATED THREE TIMES WITH SIMILAR RESULTS. REPEAT DATA NOT PROVIDED. A SECOND SAMPLE WAS OBTAINED RESULTING A TOTAL BILIRUBIN OF 162 UMOL/L. THE INITIAL SAMPLE WAS SENT TO TWO DIFFERENT LABS FOR TESTING, GIVING 108 UMOL/L BY DIFFERENT ANALYZER AND 69.5 UMOL/L BY ORIGINAL ANALYZER PLATFORM - DIFFERENT METHODOLOGY. RESULTS FROM SECOND SAMPLE WERE CORRECT. ERRONEOUS RESULTS WERE NOT REPORTED. ALL THREE PATIENTS HAD SOME GALL BLADDER INFLAMMATION WITH DIFFERENT ETIOLOGY. ALL OF THEM RECEIVED INFUSION BEFORE DRAWING AND TREATMENT WITH DIFFERENT DRUGS. WHEN OTHER TREATMENTS WERE CANCELLED, DRUGS REMAINED AND RESULTS WERE THEN CORRECT. ONE PATIENT WAS SENT HOME AND THE OTHERS REMAINED IN HOSPITAL. NO INFORMATION PROVIDED TO DETERMINE WHICH PATIENT WAS SENT HOME OR REMAINED IN HOSPITAL. IF ADDITIONAL INFORMATION IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 PATIENT 2: CEFOBID| PATIENT 2: NUTRIFLEX BASAL| PATIENT 3: CEFOBID| PATIENT 3: NUTRIFLEX BASAL| PATIENT 1: NUTRIFLEX BASAL| T.J.500 ML/6 HOUR| PATIENT 1: CIPRINOL 200 MG/10| T.J. 500 ML/6HOUR| T.J. 500 ML/6 HOUR