BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION® CLINICAL CHEMISTRY SYSTEM

    MDR report key: 3930192 · Received July 11, 2014

    Report

    Report Number
    2517506-2014-00064
    Event Type
    Malfunction
    Date Received
    July 11, 2014
    Date of Event
    June 28, 2014
    Report Date
    June 29, 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
    MO, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    ORIGINAL MDR WAS SUBMITTED 07-11-2014. 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 #14-48, 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.

    Additional Manufacturer Narrative · 1

    SIEMENS HEALTHCARE DIAGNOSTICS HAS CONFIRMED COMPLAINTS OF DIMENSION(R) CHEMISTRY WASH LOT RD41041 CAUSING QC AND PATIENT SAMPLE RESULT SHIFTS. INTERNAL INVESTIGATION HAS CONFIRMED SHIFTS CAN BE ENCOUNTERED IN TWO SCENARIOS: 1.WHEN AN AFFECTED LOT OF CHEMISTRY WASH IS PLACED ON THE INSTRUMENT FOLLOWING AN UNAFFECTED LOT WITHOUT RECALIBRATION OF THE METHODS, A POSITIVE BIAS WILL BE SEEN ON CTNI, LTNI, TSH, PBNP AND LPBN. A NEGATIVE BIAS WILL BE SEEN ON FT4. 2.IF ANY OF THESE ASSAYS ARE CALIBRATED USING AN AFFECTED LOT OF CHEMISTRY WASH, QC SHOULD RETURN WITHIN RANGE; BUT WHEN A SUBSEQUENT UNAFFECTED CHEMISTRY WASH LOT IS PLACED INTO USE WITHOUT RECALIBRATION OF THE METHODS, A NEGATIVE BIAS WILL BE SEEN ON CTNI, LTNI, TSH, PBNP AND LPBN. A POSITIVE BIAS WILL BE SEEN ON FT4. SIEMENS HEALTHCARE DIAGNOSTICS INC. HAS AN ONGOING INVESTIGATION ON CHEM WASH.

    Description of Event or Problem · 1

    FALSELY ELEVATED TROPONIN I AND PBNP RESULTS WERE OBTAINED ON QC SAMPLES ON THE DIMENSION INSTRUMENT. VALUES WERE OUTSIDE LABORATORY RANGES AND NO PATIENT RESULTS WERE REPORTED TO PHYSICIANS. AFTER A CHANGE TO AN ALTERNATE LOT OF CHEMISTRY WASH, QC RESULTS RETURNED TO WITHIN LABORATORY RANGES. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED ON THE BASIS OF THE FALSELY ELEVATED TROPONIN I AND PBNP QC RESULTS. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE FALSELY ELEVATED TROPONIN I AND PBNP QC RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406254 DIMENSION® CLINICAL CHEMISTRY SYSTEM CHEM WASH MMI SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW RD41041

    Patients

    Seq Age Sex Outcome Treatment
    1