BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNOVANCE D-DIMER

    MDR report key: 6823898 · Received August 28, 2017

    Report

    Report Number
    9610806-2017-00093
    Event Type
    Malfunction
    Date Received
    August 28, 2017
    Date of Event
    August 1, 2017
    Report Date
    September 26, 2017
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
    Product Code
    DAP
    PMA / PMN Number
    K093626
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS HEALTHCARE DIAGNOSTICS INC. (SIEMENS) FILED THE INITIAL MDR 9610806-2017-00093 ON AUGUST 28, 2017. ADDITIONAL INFORMATION ((B)(6) 2017): ON (B)(6) 2017, SIEMENS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE TO DETERMINE THE CAUSE OF THE FALSE NEGATIVE D-DIMER RESULT ON THE SYSMEX CS-2100I INSTRUMENT AND FOUND NO ISSUES. THE FSE PERFORMED A PREVENTATIVE MAINTENANCE ON THE INSTRUMENT AND REPLACED AND REALIGNED THE SAMPLE PROBES AND REAGENT PROBES. ADDITIONAL INFORMATION ((B)(6) 2017): THE CUSTOMER INDICATED THEY HAVE NOT ENCOUNTERED ANY ISSUES ON THE INSTRUMENT SINCE THE FSE WAS DISPATCHED TO THE SITE. THE CAUSE OF THE FALSE NEGATIVE D-DIMER RESULT IS UNKNOWN. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS INSTRUMENT IS REQUIRED.

    Additional Manufacturer Narrative · 1

    THE PATIENT SAMPLE HAS BEEN CHECKED FOR HEMOLYSIS, ICTERUS, LIPEMIA AND MICRO-CLOTS AND NO ISSUES WERE OBSERVED. THE CUSTOMER INDICATED THAT THEY WERE NOT ABLE TO RETEST THE PATIENT FOR D-DIMER BECAUSE THEY WERE NOT ABLE TO CONTACT THE PATIENT TO OBTAIN A NEW SAMPLE. THE CAUSE OF THE ISSUE IS UNKNOWN. THE INNOVANCE D-DIMER REAGENT WITH CATALOG NUMBER 10445980 DESCRIBED IS NOT MARKETED IN THE UNITED STATES (US) AND THE PMA/510(K) NUMBER IS FOR THE US SPECIFIC REAGENTS. THE INNOVANCE D-DIMER REAGENTS MARKETED IN THE US HAVE CATALOG NUMBERS 10445981 AND 10445982.

    Description of Event or Problem · 1

    A FALSE NEGATIVE D-DIMER RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE SYSMEX CS-2100I INSTRUMENT. THE FALSE NEGATIVE RESULT WAS REPORTED TO THE PHYSICIAN, WHO QUESTIONED THE RESULT. IT IS UNKNOWN WHETHER ANY MEDICAL PROCEDURE OR TREATMENT WAS PERFORMED DUE TO THE FALSE NEGATIVE RESULT. THE FOLLOWING DAY, THE SAME PATIENT SAMPLE WAS RERUN, IN DUPLICATE, ON AN ALTERNATE SYSMEX CS-2100I INSTRUMENT AND THE ORIGINAL INSTRUMENT. THE SAMPLE WAS REPEATED WITH A 1:8 DILUTION ON BOTH INSTRUMENTS, RESULTING HIGHER. IT IS UNKNOWN WHETHER A CORRECTED REPORT WAS PROVIDED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSE NEGATIVE D-DIMER RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603734 INNOVANCE D-DIMER INNOVANCE D-DIMER DAP SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH INNOVANCE D-DIMER 46678

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR