BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA® UREA NITROGEN FLEX® REAGENT CARTRIDGE

    MDR report key: 5499687 · Received March 14, 2016

    Report

    Report Number
    2517506-2016-00128
    Event Type
    Malfunction
    Date Received
    March 14, 2016
    Date of Event
    December 30, 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
    CT, 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 FEBRUARY 2016, COMMUNICATION VC-16.01.B.US TO ALL U.S ACCOUNTS OR AN URGENT FIELD SAFETY NOTICE VC-16-01.B.OUS, 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 FLEX CARTRIDGE AND HIGHER RESULTS WERE OBTAINED WITHIN LABORATORY RANGES. THERE IS NO INDICATION THAT ERRONEOUS PATIENT RESULTS WERE REPORTED. THERE IS NO INDICATION THAT PATIENT TREATMENT WAS ALTERED OR PRESCRIBED ON THE BASIS OF DISCREPANT BUN RESULTS. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE DISCREPANT BUN RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155110 DIMENSION VISTA® UREA NITROGEN FLEX® REAGENT CARTRIDGE DIMENSION VISTA® UREA NITROGEN FLEX® REAGENT CARTRIDGE CDQ SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW 10445159 15320BB

    Patients

    Seq Age Sex Outcome Treatment
    1