BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION®

    MDR report key: 6305852 · Received February 6, 2017

    Report

    Report Number
    2517506-2017-00056
    Event Type
    Malfunction
    Date Received
    February 6, 2017
    Date of Event
    November 22, 2016
    Report Date
    February 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 Location
    VA, US
    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. THE CUSTOMER RECALIBRATED THE INSTRUMENT WITH A NEW AMM LOT EA7322 AND SET NEW RANGES FOR THE QC. THE CUSTOMER RERAN THE QC AND THE RESULTS OBTAINED WERE WITHIN THE EXPECTED RANGES. SIEMENS HEALTHCARE DIAGNOSTICS IS CONDUCTING A RECALL FOR THE DIMENSION® AMMONIA FLEX® REAGENT CARTRIDGE/AMM DF119 (SMN # (B)(4)) KIT LOTS (FB7152, EB7180, BA7194, EA7223, BA7250) AND DIMENSION VISTA® AMMONIA FLEX® REAGENT CARTRIDGE / AMM K3119 (SMN #(B)(4)) 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 US CUSTOMERS IN DECEMBER 2016. THE UFSN AND UMDR INFORMS THE CUSTOMERS TO DISCONTINUE USE OF AND DISCARD THE AFFECTED KIT LOT. THE CUSTOMER HAS STATED THAT THEY RECEIVED THE UMDR LETTER WHICH WAS MAILED AFTER THE INCIDENT OCCURRED AT THEIR LAB. 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 QC AND A PATIENT SAMPLE ON THE DIMENSION EXL SYSTEM. THE PATIENT RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. THE QC WAS RERUN AFTER RECALIBRATION AND HIGHER RESULTS WITHIN LABORATORY RANGES WERE OBTAINED. THE PATIENT SAMPLE WAS NOT RETESTED. THERE IS NO INDICATION THAT PATIENT TREATMENT WAS ALTERED OR PRESCRIBED ON THE BASIS OF THE DISCORDANT LOW AMM RESULTS. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE DISCORDANT LOW AMM RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86678 DIMENSION® DIMENSION® AMM AMMONIA FLEX® REAGENT CARTRIDGE JIF SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW FB7152

    Patients

    Seq Age Sex Outcome Treatment
    1