BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA® SYSTEM

    MDR report key: 4998325 · Received August 12, 2015

    Report

    Report Number
    9610806-2015-00027
    Event Type
    Malfunction
    Date Received
    August 12, 2015
    Date of Event
    April 27, 2015
    Report Date
    July 17, 2015
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
    Product Code
    JZG
    PMA / PMN Number
    K083463
    Removal / Correction Number
    2517506-07232015-005-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS HEALTHCARE DIAGNOSTICS HAS CONFIRMED AN INCREASE IN THE RATE OF "ABNORMAL ASSAY" ERRORS AND CALIBRATION FAILURES WITH THE DIMENSION VISTA(R) B2MIC FLEX(R) REAGENT CARTRIDGE LOT 15037MA. THE ERRORS CAN OCCUR ON CALIBRATION, QC AND/OR PATIENT SAMPLES. AS STATED IN THE DIMENSION VISTA OPERATOR'S GUIDE, RESULTS WITH ABNORMAL ASSAY FLAGS ARE NOT REPORTABLE. SIEMENS HEALTHCARE DIAGNOSTICS ISSUED AN URGENT MEDICAL DEVICE RECALL COMMUNICATION, 15-51, DATED JULY 2015 INSTRUCTING CUSTOMERS TO DISCONTINUE USE OF B2MIC LOT 15037MA AS A RESULT OF THE ISSUE. CUSTOMERS WERE INSTRUCTED TO DISCARD ANY REMAINING INVENTORY OF THE LOT AND TO CONTACT SIEMENS HEALTHCARE DIAGNOSTICS FOR REPLACEMENT PRODUCT. NOTE DUE TO PROBLEM WITH FDA SUBMISSION WEBSITE; CODES CAUSED REJECTION OF ESUBMISSION GATEWAY: CODES WHICH WOULD HAVE BEEN USED ARE: (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A HIGH FREQUENCY OF FLAGGED ABNORMAL ASSAY RESULTS ON QC AND PATIENT SAMPLES WITH THE BETA-2 MICROGLOBULIN (B2MIC) FLEX (R) REAGENT CARTRIDGE ON THE DIMENSION VISTA INSTRUMENT. RESULTS WITH ABNORMAL ASSAY ERRORS WERE NOT REPORTED TO PHYSICIANS. THERE IS NO INDICATION THAT PATIENT TREATMENT WAS ALTERED OR PRESCRIBED ON THE BASIS OF THE HIGH FREQUENCY OF FLAGGED ABNORMAL ASSAY FLAGS WITH THE B2MIC REAGENT. THERE IS NO INDICATION OF ADVERSE PATIENT IMPACT DUE TO THE HIGH FREQUENCY OF FLAGGED ABNORMAL ASSAY FLAGS WITH THE B2MIC REAGENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530326 DIMENSION VISTA® SYSTEM B2MIC FLEX® REAGENT CARTRIDGE AND URINE STABILIZER JZG SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1