BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION XTRA

    MDR report key: 3103547 · Received May 9, 2013

    Report

    Report Number
    2954323-2013-00263
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 17, 2013
    Report Date
    April 17, 2013
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PARAMEDIC

    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.

    Additional Manufacturer Narrative · 1

    THE REPORTED METER WAS RETURNED AND INVESTIGATED WITH RETURNED 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. THE READING THE CUSTOMER REPORTED WAS FOUND IN METER MEMORY.

    Description of Event or Problem · 1

    A HEALTHCARE PROVIDER (PARAMEDIC) REPORTED THAT ON (B)(6) 2013 AT 8:00 AM, THE CUSTOMER WAS HALLUCINATING, WAS CONFUSED AND DISORIENTED AND SUBSEQUENTLY FELL AND COULD NOT GET UP. PARAMEDICS WERE CALLED AND UPON ARRIVAL PERFORMED A GLUCOSE TEST USING CUSTOMER'S ADC BLOOD GLUCOSE METER AT 8:26 AM AND RECEIVED A READING OF 354 MG/DL. PARAMEDICS PROVIDED CUSTOMER WITH OXYGEN, AN INTRAVENOUS INFUSION OF NORMAL SALINE WAS INITIATED AND TRANSPORTED HIM TO A LOCAL HEALTHCARE FACILITY. AT THE HOSPITAL, A READING OF 50 MG/DL WAS RECEIVED AT 8:42 AM FROM THE HOSPITAL'S LABORATORY AND CUSTOMER WAS DIAGNOSED WITH HYPOGLYCEMIA. NO FURTHER INFORMATION WAS PROVIDED BY THE PARAMEDICS AND BECAUSE THEY DECLINED TO DOCUMENT THE CUSTOMER'S CONTACT INFORMATION, FURTHER FOLLOW-UP WITH THE CUSTOMER IS NOT POSSIBLE. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203524 PRECISION XTRA BLOOD GLUCOSE MONITORING SYSTEM NBW 49670

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R