BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA CLINICAL CHEMISTRY SYSTEM

    MDR report key: 3180712 · Received June 20, 2013

    Report

    Report Number
    1226181-2013-00275
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    May 21, 2013
    Report Date
    May 21, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    PMA / PMN Number
    K051087
    Removal / Correction Number
    1226181-06/27/2013-003-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS TECHNICAL SOLUTIONS CENTER (TSC). AFTER EVALUATION OF THE INSTRUMENT DATA, THE TSC SPECIALIST DISCOVERED THAT THE SAMPLES HAD BEEN DISPENSED INTO ALIQUOT WELLS THAT HAD ALREADY BEEN USED FOR QUALITY CONTROLS. THE CAUSE OF THE ALIQUOT WELLS BEING REUSED IS UNKNOWN. SIEMENS IS INVESTIGATING THIS ISSUE.

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR 1226181-2013-00275 WAS FILED ON JUNE 20, 2013. ADDITIONAL INFORMATION (6/19/13): SIEMENS HEALTHCARE DIAGNOSTICS HAS INVESTIGATED THE INCIDENCE OF PATIENT SAMPLES BEING DISPENSED INTO AN ALIQUOT WELL THAT QUALITY CONTROL OR CALIBRATION MATERIAL FROM A VISTA VIAL HAS ALREADY BEEN DISPENSED INTO. IT HAS BEEN CONFIRMED THAT THE ISSUE CAN OCCUR ON DIMENSION VISTA INSTRUMENTS THAT USE SOFTWARE VERSIONS 3.5.1 AND 3.6 DURING CONDITIONS REQUIRING A SYSTEM RESET. AN URGENT MEDICAL DEVICE CORRECTION (UMDC), UMDC 13-49: DIMENSION VISTA 500/DIMENSION VISTA 1500 ALIQUOT WELL DOUBLE DISPENSE, WAS SENT TO CUSTOMERS IN JUNE 2013. THE UMDC INSTRUCTS CUSTOMERS TO CHECK FOR PENDING QUALITY CONTROL OR CALIBRATION TESTS IF THE SYSTEM REQUIRES A RESET AND IF SO, TO RESTART THE SOFTWARE PRIOR TO PROCESSING PATIENT SAMPLES.

    Description of Event or Problem · 1

    DISCORDANT RESULTS WERE OBTAINED ON PATIENT SAMPLES FOR MULTIPLE ASSAYS ON A DIMENSION VISTA 1500 INSTRUMENT. IT IS UNKNOWN IF THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). SOME SAMPLES WERE RERUN ON THE SAME INSTRUMENT AND AN ALTERNATE INSTRUMENT AND RESULTED DIFFERENTLY UPON REPEAT TESTING. IT IS UNKNOWN IF THE RERUN RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280846 DIMENSION VISTA CLINICAL CHEMISTRY SYSTEM CLINICAL CHEMISTRY SYSTEM JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA 1500

    Patients

    Seq Age Sex Outcome Treatment
    1