BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION®

    MDR report key: 6152962 · Received December 7, 2016

    Report

    Report Number
    2517506-2016-00497
    Event Type
    Malfunction
    Date Received
    December 7, 2016
    Date of Event
    November 14, 2016
    Report Date
    January 6, 2017
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
    Product Code
    JIF
    PMA / PMN Number
    K123320
    Removal / Correction Number
    2517506-12/27/2016-004-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC). THE CAUSE OF THE DISCORDANT AMM RESULTS IS UNKNOWN. SIEMENS IS INVESTIGATING THE ISSUE. NOTE: THE FOREIGN ACCOUNT IS IN THE COUNTRY OF (B)(6) WHICH IS NOT A DROPDOWN OPTION.

    Additional Manufacturer Narrative · 1

    ORIGINAL MDR 2517506-2016-00497 WAS FILED 2016-12-07. (B)(4) SIEMENS HEALTHCARE DIAGNOSTICS IS CONDUCTING A RECALL FOR THE DIMENSION® AMMONIA FLEX® REAGENT CARTRIDGE/AMM DF119 (SMN # 10711991) KIT LOTS (FB7152, EB7180, BA7194, EA7223, BA7250) AND DIMENSION VISTA® AMMONIA FLEX® REAGENT CARTRIDGE / AMM K3119 (SMN #10711992) KIT LOTS (16187BE, 16225BB, 16265AB). SIEMENS HEALTHCARE DIAGNOSTICS HAS DETERMINED THAT DIMENSION AMM (DF119) FLEX REAGENT CARTRIDGE LOTS FB7152, EB7180, BA7194, EA7223, BA7250 AND DIMENSION VISTA AMM (K3119) FLEX REAGENT CARTRIDGE FLEX LOTS 16187BE, 16225BB, 16265AB DO NOT MEET THE 60-DAY CALIBRATION INTERVAL CLAIM DUE TO REAGENT INSTABILITY AND RESULTS MAY SHOW AN ABNORMAL ASSAY. THESE LOTS MAY EXHIBIT ACCURACY SHIFTS FOR PATIENT AND/OR QUALITY CONTROL RESULTS; WHICH MAY CAUSE LABORATORIES TO RECALIBRATE MORE FREQUENTLY THAN THE 60-DAY CLAIM IN THE INSTRUCTIONS FOR USE (IFU). AN URGENT FIELD SAFETY NOTICES (UFSN'S) DC17-01.A.OUS.DM AND DC 17.01A.OUS.DMV WERE SENT TO OUS CUSTOMERS AND AN URGENT MEDICAL DEVICE RECALLS (UMDR'S) DC17-01.A.US.DM AND DC 17.01A.US.DMV WERE SENT TO U.S. CUSTOMERS IN DECEMBER 2016. THE UFSN AND UMDR INFORMS THE CUSTOMERS TO DISCONTINUE USE OF AND DISCARD THE AFFECTED KIT LOT. SIEMENS RECOMMENDS USING AN ALTERNATE LOT OF DIMENSION OR DIMENSION VISTA AMM. SIEMENS IS CURRENTLY INVESTIGATING THE ROOT CAUSE OF THIS ISSUE.

    Description of Event or Problem · 1

    DISCORDANT LOW AMMONIA (AMM) RESULTS WERE OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION EXL SYSTEM. THE PATIENT RESULTS WERE NOT REPORTED TO THE PHYSICIAN. THE ACCOUNT REGARDED THE INITIAL RESULT AS DISCORDANT. IT IS UNKNOWN IF CORRECTED RESULTS WERE REPORTED. THERE IS NO INDICATION THAT PATIENT TREATMENT WAS ALTERED OR PRESCRIBED ON THE BASIS OF THE DISCORDANT AMM RESULTS. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE DISCORDANT AMM RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803124 DIMENSION® DIMENSION® AMM AMMONIA FLEX® REAGENT CARTRIDGE JIF SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW EB7180

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR