BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASSURE 4 BLOOD GLUCOSE SYSTEM

    MDR report key: 1904413 · Received November 22, 2010

    Report

    Report Number
    1832816-2010-00023
    Event Type
    Injury
    Date Received
    November 22, 2010
    Date of Event
    October 25, 2010
    Report Date
    October 25, 2010
    Manufacturer
    APEX BIOTECHNOLOGY CORP.
    Product Code
    CGA
    PMA / PMN Number
    K070088
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ACTUAL PRODUCT WAS NOT RETURNED FOR TESTING. RETENTION SAMPLES OF THE SAME LOT OF TEST STRIPS INVOLVED IN THE INCIDENT WERE TESTED AND PERFORMED TO SPECIFICATION. CUSTOMER DID NOT RETURN PRODUCT.

    Description of Event or Problem · 1

    CALLER INDICATED THE ASSURE 4 METER WAS READING HIGH. AT 9:00AM, PT WASN'T FEELING WELL AND COMPLAINING FOR STOMACH ACHE. WASN'T GIVEN 9AM MED DUE TO THIS. AT 9:30AM, WAS TAKEN DOWN FOR BREAKFAST. SHE DID NOT EAT BREAKFAST. SHE WAS BROUGHT BACK TO ROOM IN WHEELCHAIR. PT WAS NON RESPONSIVE AT THIS POINT. BG WAS TAKEN READING WAS 94. AMBULANCE WAS CALLED DUE TO NON RESPONSIVENESS AND LOW BLOOD PRESSURE. WHEN EMT ARRIVED, THEY TOOK HER BG AND IT READ 50. GLUCAGON WAS ADMINISTERED IM. PT BECAME RESPONSIVE AND WAS TAKEN TO THE HOSPITAL.

    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 SS040F

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R