BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTIME MICROCOAGULATION SYSTEM

    MDR report key: 2181436 · Received July 6, 2011

    Report

    Report Number
    2248721-2011-00081
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Date of Event
    June 8, 2011
    Report Date
    June 9, 2011
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP.
    Product Code
    GKP
    PMA / PMN Number
    K951072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) (CUVETTE LOT #D1P3C172). METHOD: DEVICE HAS BEEN REQUESTED. NO PRODUCT RETURNED. DEVICE HISTORY RECORD FOR CUVETTE LOT WAS REVIEWED AND MET SPECIFICATIONS. RESULT: CUSTOMER COMPLAINT COULD NOT BE CONFIRMED. CONCLUSION: NO CONCLUSION CAN BE DRAWN. ITC HAS REQUESTED ALL DATA REQUIRED FOR FORM 3500A.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTS LOWER THAN EXPECTED RESULT FOR PATIENT ON PROTIME MICROCOAGULATION SYSTEM. THE PATIENT GENERATED INR 1.4. THE TEST WAS REPEATED BY LAB DRAW ON THE SAME DAY. LAB INR RESULT WAS 2.1. PATIENT'S THERAPEUTIC RANGE 2.0-3.0. NO ADVERSE EVENT(S) REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1