BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTIME MICROCOAGULATION SYSTEM

    MDR report key: 1920957 · Received November 10, 2010

    Report

    Report Number
    2248721-2010-00161
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 13, 2010
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP.
    Product Code
    GKP
    PMA / PMN Number
    K951072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR SUBMITTED (B)(4) 2010 REFERENCES ITC COMPLAINT (B)(4). METHOD: PRODUCT EVALUATED. DEVICE HISTORY RECORD, NCMR, CAPA AND COMPLAINT HISTORY EVALUATED. RESULT: DEVICE PERFORMED ACCORDING TO SPECIFICATIONS. CONCLUSION: DEVICE EVALUATED AND ALLEGED FAILURE COULD NOT BE DUPLICATED. ITC COMPLAINT CASE ADDITIONAL REFERENCE: (B)(4): MDR# 2248721-2010-00162.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ONE OCCURRENCE OF INR LOW ON A PROTIME INSTRUMENT. NO FURTHER DETAILS REGARDING THE OCCURRENCE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTIME MICROCOAGULATION SYSTEM PROTIME INSTRUMENT GKP INTERNATIONAL TECHNIDYNE CORP. L11-01-01 CUVETTE: G0K3C43

    Patients

    Seq Age Sex Outcome Treatment
    1