BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION XTRA

    MDR report key: 3882287 · Received June 18, 2014

    Report

    Report Number
    2954323-2014-00691
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    May 17, 2014
    Report Date
    May 23, 2014
    Product Code
    NBW
    PMA / PMN Number
    K040814
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ORIGINAL MDR (NO: 2954323-2014-00691) ERRONEOUSLY INDICATED THE REPORT WAS BEING SUBMITTED FOR BOTH A SERIOUS INJURY AND A MALFUNCTION. THE MDR SHOULD HAVE INDICATED THE MDR WAS ONLY BEING SUBMITTED AS A SERIOUS INJURY.

    Additional Manufacturer Narrative · 1

    IT SHOULD BE NOTED: THE TEST STRIPS THE CUSTOMER WAS USING EXPIRED IN FEBRUARY, 2012. REPORT IS BEING SENT AS AN INITIAL/FINAL, AS USE ERROR CAUSED OR CONTRIBUTED TO THE EVENT. CUSTOMER USED TEST STRIPS OUTSIDE OF WARRANTY; THEREFORE NO INVESTIGATION WILL BE UNDERTAKEN. THE METER'S DATE OF MANUFACTURE IS UNKNOWN. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT ON (B)(6) 2014 AT 18:00, WHILE IN A COFFEE SHOP HE BEGAN TO FEEL "FAINT AND WAS SWEATING". CUSTOMER TESTED USING HIS ADC BLOOD GLUCOSE METER AND RECEIVED A READING "AROUND 100 SOMETHING" (CUSTOMER COULD NOT RECALL EXACT READING). PARAMEDICS WERE CALLED AND TRANSPORTED HIM TO A LOCAL HEALTHCARE FACILITY. AT THE HOSPITAL A READING OF 449 MG/DL WAS RECEIVED ON AN UNKNOWN INSTRUMENT AND CUSTOMER'S "HEART WAS CHECKED". CUSTOMER WAS DIAGNOSED WITH HYPERGLYCEMIA AND TREATED WITH INSULIN AND UNSPECIFIED "SERUM". ANOTHER TEST WAS PERFORMED USING THE ADC METER AND AGAIN A READING OF "100 SOMETHING" RECEIVED. CUSTOMER WAS ALSO DIAGNOSED WITH DIGITALIS TOXICITY. PRIOR TO BEING SENT HOME A READING OF 171 MG/DL WAS OBTAINED ON THE HOSPITAL METER. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358712 PRECISION XTRA BLOOD GLUCOSE MONITORING SYSTEM NBW 45001C165

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention