BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION XTRA

    MDR report key: 2031886 · Received March 28, 2011

    Report

    Report Number
    2954323-2011-02666
    Event Type
    Injury
    Date Received
    March 28, 2011
    Date of Event
    February 18, 2011
    Report Date
    March 28, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. NOTE: THE DEVICE MANUFACTURING DATE IS UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER SENT A CORRESPONDENCE TO ADC IN WHICH THEY REPORTED THEY RECEIVED A READING OF 425 MG/DL ON THEIR PRECISION XTRA BLOOD GLUCOSE METER, AND AFTER CONSULTING THEIR DOCTOR, THEY INCREASED THEIR INSULIN INTAKE. THE CUSTOMER REPORTEDLY EXPERIENCED SYMPTOMS OF HYPOGLYCEMIA (NOT SPECIFIED), BUT THEIR METER SHOWED A READING OF 111 MG/DL. THE CUSTOMER ALSO REPORTED THAT THREE DAYS LATER (BY (B)(6) 2011) THEY WERE ADMITTED TO A HOSPITAL AND "TOOK THE DOCTOR TWO DAYS TO STABILIZE THEIR BLOOD SUGAR LEVELS". NO SPECIFIC MEDICAL DIAGNOSIS OR TREATMENT WAS REPORTED. NO ADDITIONAL INFORMATION ABOUT THE DEVICE SERIAL NUMBER AND TEST STRIP LOT WAS PROVIDED AS WELL. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization