BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCELERATOR APS

    MDR report key: 2853192 · Received July 29, 2008

    Report

    Report Number
    1628664-2008-00322
    Event Type
    Malfunction
    Date Received
    July 29, 2008
    Report Date
    July 14, 2008
    Manufacturer
    INPECO SPA
    Product Code
    JQP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT THE INPECO SYSTEM MODULE FOR THEIR ARCHITECT C8000 ANALYZER GENERATED SAMPLE PRESENTATION ERRORS AT MODULE #4 AND AS A CONSEQUENCE, THERE WAS ONE PATIENT RESULT THAT WAS HELD ON AMS (MIDDLEWARE) BUT INCORRECTLY REPORTED OUT OF THE LABORATORY. THE SAMPLE AFFECTED HAD A URINE AND ELECTROLYTE PANEL ORDERED. A CRP WAS PERFORMED ON THE URINE SAMPLE INSTEAD OF THE SERUM SAMPLE AND WAS REPORTED OUT OF THE LAB. THE CUSTOMER HAD NOTICED THE ERROR AND IMMEDIATELY RETESTED THE SAMPLE AND REPORTED A CORRECTED RESULT. THE CUSTOMER HAS ADDED A RULE TO THE AMS SOFTWARE TO HOLD ALL SAMPLES AFFECTED BY SAMPLE PRESENTATION ERRORS UNTIL CONFIRMED. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCELERATOR APS AUTOMATED SAMPLE HANDLING AND PROCESSING SYSTEM JQP INPECO SPA NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI CLIN CHEM CRP ASSAY:| ARCHITECT C8000 ANALYZER:| LIST#: 8G65-20| LIST#: 1G06-041, SERIAL#: (B)(4)