BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK CARE SYSTEM

    MDR report key: 38369 · Received August 30, 1996

    Report

    Report Number
    1823260-1996-00085
    Event Type
    Malfunction
    Date Received
    August 30, 1996
    Date of Event
    August 14, 1996
    Report Date
    August 30, 1996
    Manufacturer
    BOEHRINGER MANNHEIM CORP.
    Product Code
    GFO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL MANUFACTURER'S REPORT 1823260-1996-00085 INDICATED INCORRECTLY IN BLOCK B1 THAT THE REPORT INOVLVED AN ADVERSE EVENT. THE EVENT INVOLVED A PRODUCT PROBLEM. FOR THIS REASON, THE PT INFO IS NOT APPLICABLE (NA). NO ADVERSE EFFECT TO ANY PT WAS NOTED. NO MEDICATION OR MEDICAL TREATMENT WAS GIVEN BASED ON THE PRODUCT MALFUNCTION. THIS INFO WAS NOT RECEIVED BY CO FROM A USER FACILITY REPORT. CO IS THE MANUFACTURER OF THE DEVICE, NOT THE USER FACILITY. THUS BLOCK F IS NOT

    Description of Event or Problem · 1

    A PT WHOSE INR IS USUALLY 4.0, WAS FOUND TO BE 7.6, 5.5 AND 4.1 WITH NEW STRIPS LOTS AND OLD CONVERSION CHART. WHEN THE CORRECT CONVERSION CHART WAS USED, VALUES OF 5.1, 4.0 AND 3.24 WERE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAGUCHEK CARE SYSTEM PROTHROMBIN TIME TEST SYSTEM GFO BOEHRINGER MANNHEIM CORP. 770 (METER) 300033 (STRIPS)

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Hospitalization