BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 1483282 · Received July 22, 2009

    Report

    Report Number
    1823260-2009-05123
    Event Type
    Malfunction
    Date Received
    July 22, 2009
    Date of Event
    March 9, 2009
    Report Date
    July 22, 2009
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    DKJ
    PMA / PMN Number
    K953239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CUSTOMER STATED HE RECEIVED 3 POSITIVE SALICYLATE RESULTS ON EXTERNAL PROFICIENCY SAMPLES WHICH SHOULD HAVE RESULTED AS NEGATIVE. TWO OF THE SAMPLES WERE FOUND TO HAVE DISCREPANT RESULTS: SAMPLE 1 GAVE 39.3 MG/DL, REPEATED (B) (6) 2009 GAVE 39.6 MG/DL. SAMPLE 2 GAVE 40.9 MD/DL, REPEATED (B) (6) 2009 GAVE 40.4 MG/DL. PER SURVEY VENDOR, THERE WAS NO SALICYLATE PRESENT IN THE CHALLENGE SAMPLES. CUSTOMER STATED THEY DID NOT CONVERT THE SALICYLATE RESULTS TO THE CORRECT UNITS WHEN REPORTING THE SURVEY, HOWEVER, EVEN AFTER CORRECTION TO THE CORRECT UNITS, THE RESULTS ARE STILL CONSIDERED DISCREPANT. NO ERRONEOUS OR DISCREPANT PT RESULTS WERE GENERATED. IF ADDITIONAL INFO 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 DKJ ROCHE DIAGNOSTICS P MODULE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK