BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNOVANCE® D-DIMER

    MDR report key: 6861375 · Received September 13, 2017

    Report

    Report Number
    9610806-2017-00102
    Event Type
    Malfunction
    Date Received
    September 13, 2017
    Date of Event
    August 18, 2017
    Report Date
    October 16, 2017
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
    Product Code
    DAP
    UDI-DI
    00842768022821
    PMA / PMN Number
    K093626
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS HEALTHCARE DIAGNOSTICS INC. (SIEMENS) FILED THE INITIAL MDR 9610806-2017-00102 ON SEPTEMBER 13, 2017. ADDITIONAL INFORMATION (SEPTEMBER 18, 2017): THE CUSTOMER INDICATED THAT THEY WILL DISCONTINUE THE USE OF RECYCLED CUVETTE ROTORS. THE CUSTOMER RESUMED THE USE OF BARBICIDE DISINFECTANT AND THE CUSTOMER HAS NOT EXPERIENCED ANY ISSUES SINCE THEY USED NEW CUVETTE ROTORS FOR SAMPLE AND CONTROL DETERMINATION. ADDITIONAL INFORMATION (SEPTEMBER 21, 2017): SINCE SEPTEMBER 11, 2017, ALL D-DIMER QUALITY CONTROLS RECOVERED WITHIN EXPECTED RANGES. THE INTERNAL QUALITY CONTROLS FOR THE OTHER ASSAYS ALSO RECOVERED WITHIN EXPECTED RANGES. ADDITIONAL INFORMATION (SEPTEMBER 22, 2017): A SIEMENS HEADQUARTERS SUPPORT CENTER (HSC) SPECIALIST REVIEWED THE EVENT AND FIELD SERVICE REPORTS AND DETERMINED THAT THE CAUSE OF THE POTENTIAL FALSE NEGATIVE D-DIMER RESULTS ON THE BCS XP SYSTEM WAS DUE TO THE CUSTOMER'S USE OF RECYCLED CUVETTE ROTORS. MDR 9610806-2017-00098_S1, MDR 9610806-2017-00099_S1, MDR 9610806-2017-00100_S1, AND MDR 9610806-2017-00101_S1 WERE FILED FOR THE SAME EVENT.

    Additional Manufacturer Narrative · 1

    A SIEMENS HEALTHCARE DIAGNOSTICS INC. (SIEMENS) CUSTOMER SERVICE ENGINEER (CSE) AND A TECHNICAL APPLICATION SPECIALIST (TAS) WERE DISPATCHED TO THE CUSTOMER'S SITE TO DETERMINE THE CAUSE OF THE POTENTIAL FALSE NEGATIVE D-DIMER RESULTS ON THE BCS XP SYSTEM. DURING THE INVESTIGATION, THE CSE OBSERVED THAT THE CALIBRATION CURVE, USED TO RUN PATIENT SAMPLES, ON THE BCS XP SYSTEM WAS UNACCEPTABLE. THE CSE CHANGED THE REAGENT LOT, CALIBRATED THE SYSTEM, REPLACED THE SAMPLE PROBES, AND FLUSHED THE BCS XP SYSTEM OF THE BARBICIDE DISINFECTANT CLEANER. THE PRECISION TEST, VALIDATION AND LAMP WERE WITHIN SPECIFICATIONS. THE INTERNAL QC RECOVERED WITHIN EXPECTED RANGES. UPON FURTHER INVESTIGATION, SIEMENS DETERMINED THAT THE CUSTOMER IS USING RECYCLED CUVETTE ROTORS. BASED ON THE BCS® XP SYSTEM'S INSTRUCTION MANUAL, CUVETTES ARE ONLY INTENDED FOR SINGLE USE. IF USED MORE THAN ONCE, THIS COULD RESULT IN INACCURATE MEASUREMENT RESULTS. THE USE OF RECYCLED CUVETTE ROTORS IS A USER ERROR AND POTENTIALLY CONTRIBUTED TO THE DISCORDANT RESULT. SIEMENS HAS INSTRUCTED THE CUSTOMER TO DISCONTINUE THE USE OF RECYCLED CUVETTE ROTORS. THE SYSTEM IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS SYSTEM IS REQUIRED. MDR 9610806-2017-00098, MDR 9610806-2017-00099, MDR 9610806-2017-00100, AND MDR 9610806-2017-00101 WERE FILED FOR THE SAME EVENT.

    Description of Event or Problem · 1

    MULTIPLE POTENTIAL FALSE NEGATIVE D-DIMER RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES USING AN UNACCEPTABLE CALIBRATION CURVE ON THE BCS XP SYSTEM. THE D-DIMER RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO DID NOT QUESTION THE RESULTS. THE AFFECTED PATIENT SAMPLES WERE NOT RERUN AND CORRECTED REPORTS WERE NOT PROVIDED TO THE PHYSICIAN(S). THE CORRECT RESULTS FOR THE AFFECTED PATIENTS ARE UNKNOWN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE POTENTIAL FALSE NEGATIVE D-DIMER RESULTS OBTAINED ON THE PATIENT SAMPLES ON THE BCS XP SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641858 INNOVANCE® D-DIMER INNOVANCE® D-DIMER DAP SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH INNOVANCE® D-DIMER 47386 00842768022821

    Patients

    Seq Age Sex Outcome Treatment
    1