BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DADE ACTIN FSL ACTIVATED PTT REAGENT

    MDR report key: 6916861 · Received October 5, 2017

    Report

    Report Number
    9610806-2017-00109
    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
    GGW
    UDI-DI
    00842768003875
    PMA / PMN Number
    K863594
    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 DIRECTED THE CUSTOMER TO RUN A PRECISION TEST TO DETERMINE THE CAUSE OF THE POTENTIALLY DISCORDANT ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) 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 IS 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 APTT RESULTS IS UNKNOWN. THE SYSTEM IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS SYSTEM IS REQUIRED. MDR 9610806-2017-00107 AND MDR 9610806-2017-00108 WERE FILED FOR THE SAME EVENT.

    Description of Event or Problem · 1

    A POTENTIALLY DISCORDANT ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) 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 RERUN ON THE SAME SYSTEM, RESULTING LOWER. THE REPEATED RESULT WAS NOT 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 CONTROL RECOVERED WITHIN EXPECTED RANGES. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE POTENTIALLY DISCORDANT APTT RESULTS OBTAINED ON THIS PATIENT SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697867 DADE ACTIN FSL ACTIVATED PTT REAGENT DADE ACTIN FSL ACTIVATED PTT REAGENT GGW SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH DADE ACTIN FSL ACTIVATED PTT REAGENT 547496A 00842768003875

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR