BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA® UREA NITROGEN FLEX® REAGENT CARTRIDGE

    MDR report key: 5465634 · Received February 28, 2016

    Report

    Report Number
    2517506-2016-00037
    Event Type
    Malfunction
    Date Received
    February 28, 2016
    Date of Event
    December 18, 2015
    Report Date
    February 16, 2016
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
    Product Code
    CDQ
    PMA / PMN Number
    K051087
    Removal / Correction Number
    2517506-02-26-2016-002-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS HEALTHCARE DIAGNOSTICS HAS DETERMINED THAT DIMENSION VISTA® BLOOD UREA NITROGEN (BUN) LOTS 15215AE, 15243BB, 15264BA, 15299BB, 15300BA, 15320BB, AND 15341AC MAY EXHIBIT INACCURATE PATIENT AND/OR QUALITY CONTROL RESULTS. ONLY SPECIFIC REAGENT CARTRIDGE WELLS ARE AFFECTED. IF CALIBRATION IS PERFORMED USING AN UNAFFECTED WELL AND PATIENT RESULTS ARE SUBSEQUENTLY RUN USING AN AFFECTED WELL, BUN RESULTS MAY BE FALSELY DEPRESSED BY UP TO APPROXIMATELY 50%. IF CALIBRATION IS PERFORMED USING AN AFFECTED WELL, BUN RESULTS MAY BE FALSELY ELEVATED BY UP TO APPROXIMATELY 64%. SIEMENS ISSUED AN URGENT MEDICAL DEVICE CORRECTION DATED (B)(6) 2016, COMMUNICATION (B)(4) TO ALL U.S ACCOUNTS OR AN URGENT FIELD SAFETY NOTICE (B)(4), TO ALL OUTSIDE U.S. ACCOUNTS WHO HAD BEEN SHIPPED THE IMPACTED LOTS. CUSTOMERS WERE DIRECTED TO DISCARD CERTAIN FLEXES WITH A SPECIFIC LOT NUMBER/CAVITY NUMBER COMBINATION. SIEMENS OFFERED A NO CHARGE REPLACEMENT OR CREDIT FOR DISCARDED INVENTORY.

    Description of Event or Problem · 1

    THE CUSTOMER NOTED DISCREPANT LOW BUN QC RESULTS WITHIN A DIMENSION VISTA FLEX(R) REAGENT CARTRIDGE WELL SET. THE SAMPLES WERE REPEATED ON AN ALTERNATE WELL SET AND HIGHER RESULTS WERE OBTAINED. THERE IS NO INDICATION THAT PATIENT TREATMENT WAS ALTERED OR PRESCRIBED ON THE BASIS OF DISCREPANT LOW BUN RESULTS. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE DISCREPANT LOW BUN RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122072 DIMENSION VISTA® UREA NITROGEN FLEX® REAGENT CARTRIDGE DIMENSION VISTA® UREA NITROGEN FLEX® REAGENT CARTRIDGE CDQ SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW 10445159 15215AE

    Patients

    Seq Age Sex Outcome Treatment
    1