BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNOVANCE D-DIMER

    MDR report key: 10028723 · Received May 6, 2020

    Report

    Report Number
    9610806-2020-00016
    Event Type
    Malfunction
    Date Received
    May 6, 2020
    Date of Event
    April 9, 2020
    Report Date
    June 2, 2020
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
    Product Code
    DAP
    UDI-DI
    00842768022814
    PMA / PMN Number
    K093626
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS FILED THE INITIAL MDR 9610806-2020-00016 ON 06-MAY-2020. ADDITIONAL INFORMATION (18-MAY-2020): SIEMENS HEALTHCARE DIAGNOSTICS INC'S INVESTIGATION HAS DETERMINED THAT QUALITY CONTROLS (QC) RECOVERED WITHIN RANGE AT THE TIME OF THE EVENT. PRECISION WAS ACCEPTABLE AND THERE WERE NO PROBLEMS WITH ANY OTHER SAMPLES. INADEQUATE MIXING, CENTRIFUGATION OR OTHER MISHANDLING OF THE SAMPLE CANNOT BE EXCLUDED AS CONTRIBUTING FACTORS TO THE DISCREPANT RESULTS. THE CUSTOMER HAS BEEN EDUCATED ON THE APPROPRIATE TROUBLESHOOTING STEPS SHOULD AN INSTANCE LIKE THIS OCCUR IN THE FUTURE. THE CUSTOMER IS OPERATIONAL. THE CAUSE OF THE EVENT IS UNKNOWN. THE REAGENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED. MDR 9610806-2020-00017_S1 WAS FILED FOR THE SAME ISSUE.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER (CCC). SIEMENS IS INVESTIGATING THE ISSUE. MDR 9610806-2020-00017 WAS FILED FOR THE DISCORDANT D-DIMER RESULT OBTAINED ON 10-APR-2020.

    Description of Event or Problem · 1

    DISCORDANT, FALSELY LOW D-DIMER RESULTS WERE OBTAINED ON A PATIENT SAMPLE ON TWO DIFFERENT SYSMEX CA-1500 SYSTEMS USING INNOVANCE D-DIMER REAGENT. WHEN THE PATIENT SAMPLE WAS INITIALLY RUN FOR D-DIMER ON A SYSMEX CA-1500 SYSTEM USING INNOVANCE D-DIMER REAGENT, THE SYSTEM GENERATED A "RANGE OVER" ERROR CODE AND DID NOT GIVE A RESULT. THE SAMPLE WAS REPEATED FOR D-DIMER ON THE SAME SYSTEM WITH THE SAME REAGENT, RECOVERING ABOVE THE LAB'S D-DIMER CUTOFF. THIS RESULT WAS CONSIDERED CORRECT AND WAS REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS THEN REPEATED FOR D-DIMER ON THE SAME SYSTEM WITH THE SAME REAGENT, RECOVERING BELOW THE CUTOFF. THIS RESULT WAS CONSIDERED DISCORDANT AND WAS NOT REPORTED TO THE PHYSICIAN(S). THE FOLLOWING DAY, THE SAME SAMPLE WAS REPEATED FOR D-DIMER ON AN ALTERNATE SYSMEX CA-1500 SYSTEM USING D-DIMER REAGENT, WHICH ALSO RECOVERED BELOW THE CUTOFF. THIS RESULT WAS ALSO CONSIDERED DISCORDANT AND WAS NOT REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW D-DIMER RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494034 INNOVANCE D-DIMER INNOVANCE D-DIMER DAP SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH INNOVANCE D-DIMER 49072 00842768022814

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR