BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION XTRA /OPTIUM

    MDR report key: 636963 · Received September 25, 2005

    Report

    Report Number
    2954323-2005-00524
    Event Type
    Injury
    Date Received
    September 25, 2005
    Date of Event
    August 10, 2005
    Manufacturer
    ABBOTT DIABETES CARE
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING A READING THAT WAS PERCEIVED TO BE A READING OF 300 MG/DL. THEIR DISPLAY WAS MISSING DIGITS. CUSTOMER INJECTED WITH 5 EXTRA UNITS OF MPH INSULIN BASED ON THE READING. CUSTOMER REGULARLY TAKES 5 UNITS OF MPH INSULIN ONCE A DAY. CUSTOMER BECAME HYPOGLYCEMIC AND LOST CONSCIOUSNESS. CUSTOMER INGESTED FOOD TO RAISE GLUCOSE LEVELS WHEN THEY REGAINED CONSCIOUSNESS. TESTING WAS CONDUCTED ON THE FINGERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION XTRA /OPTIUM BLOOD GLUCOSE METER NBW ABBOTT DIABETES CARE * 10337

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN