BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROTIME MICROCOAGULATION SYSTEM

    MDR report key: 1694218 · Received May 17, 2010

    Report

    Report Number
    2248721-2010-00081
    Event Type
    Death
    Date Received
    May 17, 2010
    Report Date
    May 18, 2010
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP.
    Product Code
    JPA
    PMA / PMN Number
    K951072
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). THE INFO DOES NOT INDICATE THE DEVICE CAUSED OR CONTRIBUTED TO THE PURPORTED DEATH. HEALTHCARE PROVIDER IS NOT RESPONSIVE TO MULTIPLE INQUIRES BY MFR. MFR AWAITING PT AND PRODUCT INFO FOR FURTHER EVAL OF THE REPORT.

    Description of Event or Problem · 1

    HEALTHCARE PROVIDER VERBALLY REPORTED ON (B) (6) 2010: PROTIME REPORTED "HIGH". THE HOSPITAL LAB REPORTED INR = 22.9 AND PT = 174.6 SECONDS. PT DID NOT DIE OF COUMADIN TOXICITY. HEALTHCARE PROVIDER REPORTED: RESULTS LOWER THAN LABORATORY VALUES ((B) (6) 2010) AND ISSUES WITH THE INSTRUMENT (BATTERY AND ERRORS) ON (B) (6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTIME MICROCOAGULATION SYSTEM PROTIME INSTRUMENT JPA INTERNATIONAL TECHNIDYNE CORP. PROTIMEPRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| O