BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DADE INNOVIN

    MDR report key: 6916799 · Received October 5, 2017

    Report

    Report Number
    9610806-2017-00108
    Event Type
    Malfunction
    Date Received
    October 5, 2017
    Date of Event
    September 9, 2017
    Report Date
    October 5, 2017
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
    Product Code
    GJS
    UDI-DI
    00842768003806
    PMA / PMN Number
    K974343
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS HEALTHCARE DIAGNOSTICS INC. (SIEMENS) TECHNICAL SOLUTIONS CENTER (TSC) SPECIALIST ADVISED THE CUSTOMER TO RUN A PRECISION TEST TO DETERMINE THE CAUSE OF THE POTENTIALLY DISCORDANT PROTHROMBIN TIME (PT) RESULTS ON THE SYSMEX CA-620 SYSTEM AND THE CUSTOMER DID NOT FOLLOW THE RECOMMENDED INSTRUCTIONS. THE TSC SPECIALIST ADVISED THE CUSTOMER TO NOT REPORT PATIENT RESULTS UNTIL THE ISSUE IS RESOLVED. THE CUSTOMER INDICATED THE ISSUE WAS RESOLVED AND THEY REFUSED SERVICE. THE CUSTOMER INDICATED THAT THEY STOPPED EXPERIENCING ISSUES ONCE THEY STARTED USING CONICAL CUPS ON INTERNAL QUALITY CONTROLS. THE CAUSE OF THE POTENTIALLY DISCORDANT PT RESULTS IS UNKNOWN. THE SYSTEM IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS SYSTEM IS REQUIRED. MDR 9610806-2017-00107 AND MDR 9610806-2017-00109 WERE FILED FOR THE SAME EVENT.

    Description of Event or Problem · 1

    A POTENTIALLY DISCORDANT PROTHROMBIN TIME (PT) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE SYSMEX CA-620 SYSTEM. THIS RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAME PATIENT SAMPLE WAS REPEATED TWICE ON THE SAME SYSTEM, RESULTING LOWER. NONE OF THESE RESULTS WERE REPORTED TO THE PHYSICIAN AND THE CORRECT RESULT FOR THIS PATIENT IS UNKNOWN. PRIOR TO RUNNING THE PATIENT SAMPLE, THE CUSTOMER EXPERIENCED ISSUES WITH THE INTERNAL QUALITY CONTROLS. THE CUSTOMER INDICATED THAT INTERNAL QUALITY CONTROLS RECOVERED WITHIN RANGE ONCE SHE RAN INTERNAL QUALITY CONTROLS IN A CONICAL CUP, AS OPPOSE TO RUNNING THEM IN SAMPLE TUBES. THE CUSTOMER INDICATED THAT SHE RAN THE PATIENT SAMPLES AFTER THE INTERNAL QUALITY CONTROLS RECOVERED WITHIN EXPECTED RANGES. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE POTENTIALLY DISCORDANT PT RESULTS OBTAINED ON THIS PATIENT SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697551 DADE INNOVIN DADE INNOVIN GJS SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH DADE INNOVIN 539364 00842768003806

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR