BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION® CLINICAL CHEMISTRY SYSTEM

    MDR report key: 4060402 · Received September 4, 2014

    Report

    Report Number
    2517506-2014-00172
    Event Type
    Malfunction
    Date Received
    September 4, 2014
    Date of Event
    August 14, 2014
    Report Date
    August 14, 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
    PA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE OF THE FALSELY ELEVATED TROPONIN I RESULTS IS RETURN OF CONTAMINATION OF AN INSTRUMENT WHICH HAD PREVIOUSLY HAD CHEMISTRY WASH LOT RD41041 ON THE INSTRUMENT. A DECONTAMINATION OF THE INSTRUMENT HAD OCCURRED AFTER REMOVAL OF LOT RD41041 BUT CONTAMINATION RETURNED. 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 MEDICAL DEVICE RECALL LETTER DATED JULY 2014, COMMUNICATION # (B)(4), TO ALL ACCOUNTS WHO HAD RECEIVED THE IMPACTED LOT. SUBSEQUENTLY, SIEMENS ISSUED AN URGENT MEDICAL DEVICE RECALL UPDATE DATED AUGUST 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 WHO HAD PREVIOUSLY HAD LOT RD41041 ON THEIR SYSTEM: IF AVAILABLE, MOVE CTNI, LTNI, PBNP, LPBN, TSH, AND FT4 TESTING TO AN ALTERNATE INSTRUMENT, EITHER A DIMENSION SYSTEM WHICH WAS NOT EXPOSED TO CHEMISTRY WASH LOT RD41041 OR AN INSTRUMENT WITH AN ALTERNATE METHODOLOGY OR PLATFORM. IF THE ABOVE ACTION IS NOT POSSIBLE, PATIENT SAMPLES MUST BE BRACKETED WITH LOW LEVEL QC FOR ALL AFFECTED ASSAYS. BEFORE REPORTING PATIENT RESULTS, QC VALUES PROCESSED BEFORE AND AFTER THE PATIENT SAMPLE(S) MUST BE WITHIN ACCEPTABLE QC LIMITS. IF ANY QC VALUES ARE NOT ACCEPTABLE, DO NOT REPORT THE PATIENT RESULT(S) AND CONTACT SIEMENS FOR DIRECTION ON FURTHER ACTIONS. THE UPDATE STATED THAT SIEMENS WOULD CONTACT CUSTOMERS WITH DETAILS TO SCHEDULE REMEDIAL ACTIONS TO PREVENT FURTHER CONTAMINATION OF THEIR DIMENSION SYSTEM.

    Description of Event or Problem · 1

    FALSELY ELEVATED TROPONIN I (CTNI) PATIENT AND QC RESULTS WERE OBTAINED ON AN INSTRUMENT WHICH HAD PREVIOUSLY HAD DIMENSION® CHEMISTRY WASH LOT RD41041 INSTALLED ON THE DIMENSION SYSTEM. THYROID STIMULATING HORMONE (TSH) QC RESULTS WERE ALSO FOUND TO BE FALSELY ELEVATED. NO TSH PATIENT RESULTS WERE REPORTED. THE CTNI PATIENT RESULT WAS REPORTED TO THE PHYSICIAN. QC WAS SUBSEQUENTLY RUN AND OUT OF RANGE HIGH RESULTS OBTAINED PROMPTING REPEAT CTNI TESTING ON AN ALTERNATE DIMENSION SYSTEM. LOWER, NEGATIVE RESULTS WERE OBTAINED. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED ON THE BASIS OF THE FALSELY ELEVATED CTNI PATIENT RESULT. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE FALSELY ELEVATED CTNI PATIENT RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541816 DIMENSION® CLINICAL CHEMISTRY SYSTEM CHEMISTRY WASH MMI SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW RD41041

    Patients

    Seq Age Sex Outcome Treatment
    1