BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION® CLINICAL CHEMISTRY SYSTEM

    MDR report key: 4240896 · Received November 10, 2014

    Report

    Report Number
    2517506-2014-00317
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    October 14, 2014
    Report Date
    October 15, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
    Product Code
    JMG
    PMA / PMN Number
    K963498
    Removal / Correction Number
    2517506-07/15/2014-003-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 MEDICAL DEVICE RECALL 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. THE JULY 2014 RECALL NOTICE STATED THAT SIEMENS WOULD BE SHIPPING REPLACEMENT PRODUCT AT NO CHARGE FOR ALL ORDERS FILLED WITH LOT RD41041. AS AN ADDITIONAL PRECAUTION, A SIEMENS CUSTOMER SERVICE ENGINEER WOULD BE MAKING A VISIT TO DECONTAMINATE THE SYSTEM(S) OF CUSTOMERS WHO HAVE USED LOT RD41041. 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 ACCOUNTS 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

    THE ACCOUNT REPORTED ABNORMAL REACTION FLAGS AND IMPRECISION ON THYROXINE STIMULATING HORMONE (TSH) QC SAMPLES WITH DIMENSION® CHEMISTRY WASH LOT RD41041 INSTALLED ON THE DIMENSION SYSTEM. PATIENT RESULTS WERE NOT REPORTED TO THE PHYSICIAN. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED ON THE BASIS OF THE DISCREPANT QC SAMPLE RESULTS. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE DISCREPANT QC SAMPLE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722350 DIMENSION® CLINICAL CHEMISTRY SYSTEM CHEMISTRY WASH JMG SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW RD41041

    Patients

    Seq Age Sex Outcome Treatment
    1