BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION® CLINICAL CHEMISTRY SYSTEM

    MDR report key: 3945216 · Received July 18, 2014

    Report

    Report Number
    2517506-2014-00069
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    June 27, 2014
    Report Date
    June 27, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
    Product Code
    MMI
    PMA / PMN Number
    K963498
    Removal / Correction Number
    2517506-07/15/2014-003-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS HAS CONFIRMED BACTERIAL CONTAMINATION IN CHEMISTRY WASH LOT RD41041. A POSITIVE BIAS WILL BE OBSERVED ON CTNI, LTNI, TSH, PBNP AND LPBN AND A NEGATIVE BIAS WILL BE SEEN ON FT4 WHEN THIS LOT IS FIRST PLACED ON THE INSTRUMENT WITHOUT RECALIBRATION OF METHODS. RECALIBRATION OF THESE ASSAYS WHEN USING THIS LOT WILL NOT CORRECT THE PROBLEM AND MAY CAUSE FALSELY HIGH OR LOW RESULTS. SIEMENS ISSUED AN URGENT FIELD SAFETY NOTICE DATED JULY 2014, COMMUNICATION #(B)(4), TO ALL ACCOUNTS WHO HAD RECEIVED THE IMPACTED LOT. CUSTOMERS WERE ADVISED OF THE IMMEDIATE REMEDIAL ACTIONS TO BE TAKEN BY THE CUSTOMER: IMMEDIATELY DISCONTINUE USE AND DISCARD ALL INVENTORY OF CHEMISTRY WASH LOT RD41041. - IF THIS LOT WAS NEVER IN USE ON THE INSTRUMENT, NO FURTHER ACTION IS NEEDED. - IF THIS LOT HAD BEEN IN USE: PLACE AN ALTERNATE LOT OF CHEMISTRY WASH ON THE DIMENSION SYSTEM. PRIME THE NEW BOTTLE OF CHEMISTRY WASH 30 TIMES. RECALIBRATE THE CTNI, LTNI, TSH, FT4, PBNP AND/OR LPBN ASSAYS USING THE ALTERNATE LOT OF CHEMISTRY WASH ONBOARD. FOR THE LISTED ASSAYS, PROCESS QUALITY CONTROL EVERY 8 HOURS. SIEMENS IS SHIPPING REPLACEMENT PRODUCT AT NO CHARGE FOR ALL ORDERS FILLED WITH LOT RD41041. AS AN ADDITIONAL PRECAUTION, A SIEMENS CUSTOMER SERVICE ENGINEER WILL BE MAKING A VISIT TO DECONTAMINATE THE SYSTEM(S) OF CUSTOMERS WHO HAVE USED LOT RD41041.

    Description of Event or Problem · 1

    FALSELY ELEVATED TROPONIN I (CTNI) RESULTS WERE OBTAINED ON QC AND PATIENT WITH CHEMISTRY WASH LOT RD41041 ON THE DIMENSION INSTRUMENT.. ONLY ONE PATIENT RESULT WAS REPORTED TO THE PHYSICIAN AND WAS QUESTIONED. THE TESTING WAS REPEATED AFTER A CHANGE OF THE LOT OF CHEMISTRY WASH ON THE INSTRUMENT AND QC AND PATIENT RESULTS WERE OBTAINED WHICH WERE WITHIN EXPECTATIONS AND LAB RANGES. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED ON THE BASIS OF THE FALSELY ELEVATED CTNI RESULTS. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE FALSELY ELEVATED CTNI RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422645 DIMENSION® CLINICAL CHEMISTRY SYSTEM CHEM WASH MMI SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW RD41041

    Patients

    Seq Age Sex Outcome Treatment
    1