BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION XTRA

    MDR report key: 2942725 · Received February 4, 2013

    Report

    Report Number
    2954323-2013-00071
    Event Type
    Injury
    Date Received
    February 4, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 16, 2013
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED METER WAS RETURNED AND INVESTIGATED WITH CONTROLLED TEST STRIPS. THE COMPLAINT WAS NOT CONFIRMED AND NO NEW ISSUES WERE OBSERVED. THE METER DID POWER ON WITH BUTTON DEPRESSION AND INSERTION OF CALIBRATION BAR. THE METER DID POWER ON WITH STRIP INSERTION. LOW BATTERY ICON FLASHING WAS NOT OBSERVED.

    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. NOTE: THE DATE OF THE MEDICAL EVENT IS UNKNOWN, THE DATE ENTERED IS THE DATE WHEN ABBOTT DIABETES CARE BECAME AWARE OF THIS MEDICAL EVENT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED BEING UNABLE TO TEST DUE TO RECEIVING A LOW BATTERY ICON ON HIS ADC METER. CUSTOMER FURTHER REPORTED EXPERIENCING UNSPECIFIED SYMPTOMS. MEDICAL SURVEY WAS NOT COMPLETED BECAUSE CUSTOMER DECLINED TO CONTINUE TROUBLESHOOTING. PRIOR TO DISCONNECTING THE PHONE CALL CUSTOMER REPORTED THAT HE HAD EXPERIENCED AN UNSPECIFIED INJURY RELATED TO THIS ISSUE. 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
    46048 PRECISION XTRA BLOOD GLUCOSE MONITORING SYSTEM NBW 45001H540

    Patients

    Seq Age Sex Outcome Treatment
    1 Other