BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION XTRA

    MDR report key: 3895428 · Received June 25, 2014

    Report

    Report Number
    2954323-2014-00717
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 6, 2014
    Product Code
    NBW
    PMA / PMN Number
    K040814
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. NOTE: THE DEVICE MANUFACTURE DATE FOR THE REPORTED METER SERIAL NUMBER IS UNKNOWN. THE DATE ENTERED IN SECTION H4 IS THE COMPLAINT AWARENESS DATE. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE 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.

    Description of Event or Problem · 1

    CALLER (CUSTOMER'S WIFE) REPORTED THAT ON (B)(6) 2014 AT 6:19PM, THE CUSTOMER RECEIVED A READING OF 317 MG/DL ON HIS ADC BLOOD GLUCOSE METER WHICH WAS HIGHER THAN HE FELT. CUSTOMER SELF-TREATED WITH INSULIN AND AT 6:46PM, A READING OF 214 MG/DL WAS OBTAINED. CUSTOMER SUBSEQUENTLY TREATED WITH A "DIABETIC PILL". AT APPROXIMATELY 7:30PM, CUSTOMER BEGAN EXPERIENCING SYMPTOMS DESCRIBED AS "CONFUSED AND SWEATING". PARAMEDICS WERE CALLED AND UPON THEIR ARRIVAL AT APPROXIMATELY 8:15PM, A READING OF 40 MG/DL WAS OBTAINED ON THE PARAMEDIC METER. CALLER COULD NOT RECALL WHAT, IF ANY, TREATMENT WAS PROVIDED BY THE PARAMEDIC. CUSTOMER WAS TRANSPORTED A LOCAL HOSPITAL WHERE HE WAS DIAGNOSED WITH HYPOGLYCEMIA AND ADMINISTERED UNSPECIFIED TREATMENT VIA INTRAVENOUS INFUSION. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370016 PRECISION XTRA BLOOD GLUCOSE MONITORING SYSTEM NBW 4500162549

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention