BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOCHRON RESPONSE COAGULATION SYSTEM

    MDR report key: 1512345 · Received October 16, 2009

    Report

    Report Number
    2248721-2009-00576
    Event Type
    Malfunction
    Date Received
    October 16, 2009
    Date of Event
    September 17, 2009
    Report Date
    October 16, 2009
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP.
    Product Code
    KQG
    PMA / PMN Number
    K983475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MFR EVALUATION CURRENTLY IN PROCESS.

    Description of Event or Problem · 1

    HEALTH PROFESSIONAL REPORTS RECEIVING LOWER THAN EXPECTED ACT RESULTS USING A HEMOCHRON RESPONSE SYSTEM WHILE PERFORMING AN UNSPECIFIED PROCEDURE. AFTER RECEIVING 2 CONSECUTIVE LOWER THAN EXPECTED ACT RESULTS, PROFESSIONAL TESTS SIDE BY SIDE WITH ANOTHER HEMOCHRON RESPONSE SYSTEM. AT 11:24, ACT RESULT 442 USING HEMOCHRON RESPONSE SYSTEM VS ACT RESULT 278 USING ANOTHER HEMOCHRON RESPONSE SYSTEM. AT 11:30, ACT RESULT 325 USING HEMOCHRON RESPONSE SYSTEM VS ACT RESULT 411 USING ANOTHER HEMOCHRON RESPONSE SYSTEM. AT 11:58, ACT RESULT >1500 USING HEMOCHRON RESPONSE SYSTEM VS ACT RESULT 143 USING ANOTHER HEMOCHRON RESPONSE SYSTEM. PROFESSIONAL STARTED A NEW LOT OF ACT TUBES AS A RESULT OF THE ELEVATED ACT RESULT. AT 12:10, USING NEW LOT OF ACT TUBES, ACT RESULT 219 USING HEMOCHRON RESPONSE SYSTEM VS ACT RESULT 220 USING ANOTHER HEMOCHRON RESPONSE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOCHRON RESPONSE COAGULATION SYSTEM RESPONSE INST / ACT TUBE ASSAY KQG INTERNATIONAL TECHNIDYNE CORP. HRS.110 A9FTE016A

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other FEXOFENADINE| TRAMADOL| NASONEX| LASIX| VENTOLIN INHALER| TRAMADOL| TYLENOL| FOLIC ACID| SOTALOL| LOVENOX| CALCIUM| EXJADE| KLOR-CON| VITAMIN D| COUMADIN