BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOCHRON SIGNATURE MICROCOAGULATION SYSTEM

    MDR report key: 1665478 · Received April 16, 2010

    Report

    Report Number
    2248721-2010-00027
    Event Type
    Malfunction
    Date Received
    April 16, 2010
    Date of Event
    February 3, 2010
    Report Date
    March 16, 2010
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP.
    Product Code
    JPA
    PMA / PMN Number
    K050016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MANUFACTURER AWAITING FURTHER INFORMATION TO EVALUATE PRODUCT COMPLAINT.

    Description of Event or Problem · 1

    HEALTHCARE PROVIDER REPORTS: SIGNATURE INSTRUMENT GAVE LOWER THAN EXPECTED ACT RESULTS THAT DID NOT MATCH THE STATUS OF THREE PATIENTS. AN (B)(6) POST SENNING PROCEDURE AND WAS ON ECMO. HEMOCHRON JR. ACT-LR RESULTS: 155, 130, 142, 132, 141, 140. THE RESULTS WERE REPORTED AS LOWER FOR "K" LOT CUVETTES COMPARED TO TWO OTHER CUVETTE LOTS. NO REPORT OF ADVERSE EVENT OR SERIOUS INJURY.

    Additional Manufacturer Narrative · 2

    (B)(4). MANUFACTURER AWAITING FURTHER INFORMATION TO EVALUATE PRODUCT COMPLAINT.

    Description of Event or Problem · 2

    HEALTHCARE PROVIDER REPORTS: SIGNATURE INSTRUMENT GAVE LOWER THAN EXPECTED ACT RESULTS THAT DID NOT MATCH THE STATUS OF THREE PATIENTS. A (B)(6) POST ECMO. HEMOCHRON JR. ACT-LR RESULTS WERE REPORTED AS LOWER FOR "K" LOT CUVETTES COMPARED TO TWO OTHER CUVETTE LOTS. NO REPORT OF ADVERSE EVENT OR SERIOUS INJURY.

    Additional Manufacturer Narrative · 3

    (B)(4). MANUFACTURER AWAITING FURTHER INFORMATION TO EVALUATE PRODUCT COMPLAINT.

    Description of Event or Problem · 3

    HEALTHCARE PROVIDER REPORTS: SIGNATURE INSTRUMENT GAVE LOWER THAN EXPECTED ACT RESULTS THAT DID NOT MATCH THE STATUS OF THREE PATIENTS. A (B)(6) POST ECMO. HEMOCHRON JR. ACT-LR RESULTS REPORTED AS LOWER FOR "K" LOT CUVETTES COMPARED TO TWO OTHER CUVETTE LOTS. NO REPORT OF ADVERSE EVENT OR SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOCHRON SIGNATURE MICROCOAGULATION SYSTEM SIGNATURE INST JPA INTERNATIONAL TECHNIDYNE CORP. JACT+

    Patients

    Seq Age Sex Outcome Treatment
    1 8 MO
    2 4 YR
    3 16 YR