BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION XTRA

    MDR report key: 2082453 · Received May 10, 2011

    Report

    Report Number
    2954323-2011-03219
    Event Type
    Injury
    Date Received
    May 10, 2011
    Date of Event
    April 16, 2011
    Report Date
    May 9, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING A TROUBLESHOOTING WITH ADC CUSTOMER SERVICE IT WAS IDENTIFIED THE CUSTOMER WAS USING EXPIRED TEST STRIPS (EXP: (B)(6) 2011). THIS CASE DID NOT INVOLVE A PRODUCT MALFUNCTION. SINCE THE MEDICAL EVENT WAS RELATED TO THE USE ERROR, NO INVESTIGATION OF THE PRODUCT IS REQUIRED. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED GETTING AN ER-6 MESSAGE ON THEIR PRECISION XTRA METER AND EXPERIENCING "LACK OF ENERGY; (FEELING) HUNGRY, DEPRESSED; SLEEPING A LOT AND TINGLING FEET." THE CUSTOMER REPORTEDLY SELF-PRESENTED TO A HEATH CARE FACILITY WHERE HE WAS TREATED WITH METFORMIN AND "SOMETHING FOR HIGH CHOLESTEROL", WHICH WAS A CHANGE TO THEIR NORMAL MEDICATIONS. THE CUSTOMER DID NOT KNOW IF HE WAS DIAGNOSED WITH HYPO-OR HYPERGLYCEMIA. THE CUSTOMER ALSO SELF-TREATED WITH TYLENOL TO COUNTERACT THE EVENT. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION XTRA BLOOD GLUCOSE MONITORING SYSTEM NBW 44356

    Patients

    Seq Age Sex Outcome Treatment
    1 Other