BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASSURE 4 BLOOD GLUCOSE SYSTEM

    MDR report key: 1971103 · Received January 26, 2011

    Report

    Report Number
    1832816-2011-00004
    Event Type
    Injury
    Date Received
    January 26, 2011
    Date of Event
    January 3, 2011
    Report Date
    January 5, 2011
    Manufacturer
    APEX BIOTECHNOLOGY CORP.
    Product Code
    CGA
    PMA / PMN Number
    K070088
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT INVOLVED IN INCIDENT WAS RETURNED AND EVALUATED. THE RETURNED METER TURNS OFF AFTER POWER UP AND CAN NOT BE TESTED FURTHER. THIS DEFECT IS UNRELATED TO THE INCIDENT REPORTED. THE ROOT CAUSE IS KNOWN AND AS BEEN ADDRESSED THROUGH CORRECTIVE ACTION. THE RETURNED STRIPS PERFORMED WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    CALLER INDICATED THE ASSURE 4 WAS READING HIGH. PATIENT HAD SYMPTOMS OF LOW BLOOD SUGAR. READINGS WERE TAKEN ON TWO ASSURE 4 METERS. THE FIRST READ 82, THE SECOND READ 85. THE PARAMEDICS WERE CALLED AND WHEN THEY ARRIVED, THE PATIENTS BLOOD SUGAR WAS SO LOW THAT IT WAS UNREADABLE ON THEIR METER. THE PATIENT WAS TAKEN TO THE HOSPITAL. READINGS TAKEN BY THE ASSURE METERS AND THE METERS THE PARAMEDICS USED WERE ABOUT 10 MINUTES APART. CONTROL SOLUTION TESTS WERE WITHIN RANGE. REPLACING METERS, STRIPS, AND CONTROLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASSURE 4 BLOOD GLUCOSE SYSTEM BLOOD GLUCOSE TEST SYSTEM CGA APEX BIOTECHNOLOGY CORP. 560050 SS044Q

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| L| R