BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANCE MICRO-DRAW TEST STRIPS

    MDR report key: 697170 · Received April 7, 2006

    Report

    Report Number
    1832816-2006-00007
    Event Type
    Injury
    Date Received
    April 7, 2006
    Date of Event
    March 24, 2006
    Report Date
    March 24, 2006
    Manufacturer
    POLU-FLEX CIRCUITS, LTD
    Product Code
    CGA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CALLER INDICATED THE ADVANCE METER WAS READING HIGH. PATIENT WAS SWEATY WITH SLURRED SPEECH. DAUGHTER TRIED TO GIVE OJ, BUT PATIENT COULDN'T DRINK. ADVANCE READ 97 (NORMAL READINGS ARE USUALLY IN 160'S). EMT ARRIVED 10 MINUTES LATER AND TREATED WITH GLUCOSE IV. RETESTED AND SHE WAS UP TO 200+. METER HAS READ IN RANGE WITH CONTROLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANCE MICRO-DRAW TEST STRIPS BLOOD GLUCOSE TEST STRIPS CGA POLU-FLEX CIRCUITS, LTD 410050 12174B

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention