BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESTEPPRO TEST STRIPS

    MDR report key: 2092082 · Received May 13, 2011

    Report

    Report Number
    2092082
    Event Type
    Malfunction
    Date Received
    May 13, 2011
    Date of Event
    May 9, 2011
    Report Date
    May 13, 2011
    Manufacturer
    LIFESCAN
    Product Code
    CGA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    A PATIENT ARRIVED TO CCU (CRITICAL CARE UNIT) AT 11:00AM. POCT (POINT OF CARE TEST) WERE AS FOLLOWS: 11:00=303, 12:00=487, 13:00= GLUCOMETER READS VALUE CRITICALLY HIGH OF 519. AS PER PROTOCOL, THE NURSE OBTAINED A VENOUS BLOOD SAMPLE AND SENT IT TO THE LAB. THE RESULT WAS 294. AT 14:00 THE RESULT WAS 429 FROM POCT AND AT 14:30 THE RESULT WAS 183 FROM THE LAB DRAW. THE PATIENT WAS ON AN INSULIN DRIP AND WAS BEING DOSED BASED ON ERRONEOUS BS (BLOOD SUGAR) RESULTS AND HAD BS RESULTS LOWER THAN NORMAL. A NEW BOTTLE OF TEST STRIPS WAS OPENED AND RESULTS WERE ACCURATE. THE TEST STRIPS LOT NUMBER 3063325004 WAS QUALITY CONTROL TESTED IN THE CENTRAL LAB. BOTH LOW AND HIGH LEVELS WERE WITHIN EXPECTED RANGES. STRIPS WERE VISUALLY EXAMINED FOR DISCOLORATION AND WERE FOUND ACCEPTABLE. THE VIAL OF STRIPS WAS RETURNED TO RISK MANAGEMENT FOR FDA REPORTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURESTEPPRO TEST STRIPS SURESTEPPRO TEST STRIPS CGA LIFESCAN * 3063325004

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR NONE APPLICABLE