BEUDAMED
    FDA Adverse Event Other Summary report: N

    HEMOCHRON JR. SIGNATURE

    MDR report key: 608008 · Received May 18, 2005

    Report

    Report Number
    608008
    Event Type
    Other
    Date Received
    May 18, 2005
    Date of Event
    May 12, 2005
    Report Date
    May 18, 2005
    Manufacturer
    ITC
    Product Code
    JPA
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE HOSPITAL RAN OUT OF LOW RANGE CUVETTES FOR THE DEVICE IN 2005 WHEN 2 PATIENTS WERE BEING TESTED AT THE SAME TIME. THE MANUFACTURER PLACED FACILITY'S ORDER ON BACK-ORDER AND INSTRUCTED THE STAFF TO USE THE HIGH RANGE CUVETTES, AND REPROGRAM THE DEVICE TO THE HIGH RANGE CONTROL. THEY INSTRUCTED STAFF THAT THE RESULTS WOULD BE 20 - 25% LOWER USING THE HIGH RANGE CUVETTES SINCE THE RANGE IS BROADER AND THIS WAS TO BE TAKEN INTO CONSIDERATION. THE PATIENT WAS RECEIVING BLOOD PRODUCTS DURING THIS TIME AS WELL AS IN RESPONSE TO THEIR DIAGNOSIS. BY THE FOLLOWING WEEK THE MANUFACTURER HAD LOCATED THE LOW RANGE CUVETTES AND THEY WERE SHIPPED TO HOSPITAL. FOLLOW UP REVEALS THAT THE DEVICE WAS REPROGRAMMED FOR THE LOW RANGE CUVETTES. NOW THAT THE LOW RANGE CUVETTES ARE BEING USED THE RESULTS ARE NOT CONSISTANT WHEN COMPARED TO RESULTS FROM THE CENTRAL LAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOCHRON JR. SIGNATURE HANDHELD ACT DEVICE JPA ITC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO