BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COAGUCHEK PT TEST STRIPS

    MDR report key: 515635 · Received March 12, 2004

    Report

    Report Number
    1823260-2004-00129
    Event Type
    Injury
    Date Received
    March 12, 2004
    Date of Event
    February 15, 2004
    Report Date
    March 5, 2004
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Product Code
    JPA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE SUSPECT DEVICE READ 1.6 INR IN 2004. DR. INSTRUCTED TO HAVE PT. TAKE 4MG COUMADIN AND RESUME WITH 3MG THE NEXT DAY. UNKNOWN LAB RESULT. WAS TOLD IT WAS HIGH. FIVE DAYS LATER DEVICE READ 1.1 INR. NO STRIPS LEFT, UNKNOWN LOT. DEVICE WAS NOT CLEANED, SITE DIDN'T KNOW HOW. FAMILY MEMBER GIVES PT THEIR MEDS. STAFF AND PHYSICIAN KNOW THAT PT IS OVER MEDICATING. HAS BEEN ADMITTED TO THE HOSPITAL FOR GASTRIC BLEEDING MORE THAN ONCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAGUCHEK PT TEST STRIPS PROTHROMBIN TIME TEST STRIPS JPA ROCHE DIAGNOSTICS CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization