BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION XTRA

    MDR report key: 2873162 · Received December 13, 2012

    Report

    Report Number
    2954323-2012-06768
    Event Type
    Injury
    Date Received
    December 13, 2012
    Date of Event
    November 19, 2012
    Report Date
    November 21, 2012
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCTS HAVE BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE REPORTED METER WAS RETURNED AND INVESTIGATED WITH RETAINED TEST STRIPS. THE COMPLAINT WAS NOT CONFIRMED AND NO NEW ISSUES WERE OBSERVED. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING.

    Description of Event or Problem · 1

    CALLER (CUSTOMER'S HUSBAND) REPORTED THAT CUSTOMER WAS UNABLE TO TEST DUE TO RECEIVING AN ER-7 MESSAGE ON HER ADC METER. CUSTOMER FURTHER REPORTED THAT ON (B)(6) 2012 SHE EXPERIENCED SYMPTOMS THAT WERE DESCRIBED AS "LOW BLOOD GLUCOSE", "FELT SLEEPY AND TIRED." CUSTOMER SELF-PRESENTED TO A LOCAL HEALTH CARE FACILITY AND WAS TREATED WITH "INSULIN SHOTS ABOUT 5 MG". CUSTOMER REPORTED BEING DIAGNOSED WITH HYPOGLYCEMIA WHICH IS INCONSISTENT WITH REPORTED TREATMENT WITH INSULIN. IT SHOULD BE NOTED THAT CUSTOMER'S TEST STRIPS EXPIRED ON 31 DECEMBER 2010. ADDITIONALLY, THE TEST STRIPS WERE INCOMPATIBLE. 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 0835109

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention