BEUDAMED
    FDA Adverse Event Other Summary report: N

    PROTIME MICROCOAGULATION SYSTEM

    MDR report key: 1948681 · Received December 28, 2010

    Report

    Report Number
    2248721-2010-00181
    Event Type
    Other
    Date Received
    December 28, 2010
    Date of Event
    November 7, 2010
    Report Date
    December 2, 2010
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP.
    Product Code
    GKP
    PMA / PMN Number
    K951072
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR SUBMITTED ON (B)(6) 2010 REFERENCES (B)(4). METHOD, RESULTS AND CONCLUSIONS: MFR/EVAL/INVESTIGATION PENDING PRODUCT RETURN FROM USER FACILITY. ITC HAS REQUESTED ALL DATA REQUIRED FOR FORM 3500A.

    Description of Event or Problem · 1

    PATIENT SELF TESTER WITH A THERAPEUTIC RANGE OF 2.5 TO 3.5 INR, REPORTS THE FOLLOWING RESULTS ON HER PROTIME MICROCOAGULATION SYSTEM: PROTIME MICROCOAGULATION SYSTEM INR 3.1 ON (B)(6) 2010. LABORATORY INR 6.6 ON (B)(6) 2010. PT REPORTEDLY MAINTAINED LONG TERM REGIMEN ON COUMADIN 7.5MG WITHOUT CHANGE. PATIENT WAS ADMITTED TO HOSPITAL ON (B)(6) 2010 FOR (B)(6) DAYS WITH DIAGNOSIS OF ANEMIA AND INTERNAL BLEEDING; PATIENT RECEIVED 8 UNITS OF BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTIME MICROCOAGULATION SYSTEM PROTIME INSTRUMENT GKP INTERNATIONAL TECHNIDYNE CORP. PROTIMERPL CUVETTE: M9P3C497

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R