BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION XTRA

    MDR report key: 2172719 · Received July 22, 2011

    Report

    Report Number
    2954323-2011-03910
    Event Type
    Injury
    Date Received
    July 22, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 18, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. THE PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE LEVEL BECAUSE OF ERROR 6 MESSAGE ON HER ADC BLOOD GLUCOSE METER. CUSTOMER FURTHER REPORTED SUBSEQUENTLY EXPERIENCING DIZZINESS, NAUSEA, AND LOST CONSCIOUSNESS. WHEN CUSTOMER "CAME TO", SHE TOOK "80 UNITS OF HUMALOG INSULIN" BECAUSE SHE FELT THAT HER BLOOD GLUCOSE LEVEL WAS HIGH. CUSTOMER DID NOT SEE A DOCTOR NOR TRANSPORTED TO THE HOSPITAL. NO THIRD-PARTY MEDICAL INTERVENTION WAS REPORTED. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION XTRA BLOOD GLUCOSE MONITORING SYSTEM NBW 45001F067

    Patients

    Seq Age Sex Outcome Treatment
    1 Other