BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION XTRA

    MDR report key: 3936308 · Received July 15, 2014

    Report

    Report Number
    2954323-2014-00767
    Event Type
    Injury
    Date Received
    July 15, 2014
    Date of Event
    June 15, 2014
    Report Date
    June 18, 2014
    Product Code
    NBW
    PMA / PMN Number
    K040814
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PARAMEDIC

    Narratives

    Additional Manufacturer Narrative · 1

    METER (B)(4) WAS RETURNED AND INVESTIGATED WITH CONTROL 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 OF 8.3 MMOL/L (150 MG/DL) REPORTED BY THE HEALTH PROFESSIONAL WAS FOUND IN THE METER MEMORY.

    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 TEST STRIP LOT 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.

    Description of Event or Problem · 1

    CALLER (FIREFIGHTER/PARAMEDIC) REPORTED THAT ON (B)(6), 2014 AT 7:25AM, CUSTOMER'S CAREGIVER REPORTED THE CUSTOMER APPEARED TO BE EXPERIENCING "SYMPTOMS OF LOW BLOOD GLUCOSE" DESCRIBED AS "LOWERED CONSCIENCE LEVEL AND DIFFICULT BREATHING". CAREGIVER ADDITIONALLY REPORTED THE CUSTOMER SUFFERED A LOSS OF CONSCIOUSNESS OR SEIZURE. AN ADC BLOOD GLUCOSE METER READING OF 8.3 MMOL/L WAS OBTAINED AT AN UNSPECIFIED TIME. DOCTOR WAS CONSULTED VIA PHONE AND UPON ARRIVAL OF PARAMEDICS, AN HCP METER READING OF 1.7 MMOL/L WAS OBTAINED AND CUSTOMER WAS DIAGNOSED WITH HYPOGLYCEMIA AND ADMINISTERED GLUCOSE VIA INTRAVENOUS INFUSION. FOLLOWING TREATMENT WITH GLUCOSE AND FOOD, ADDITIONAL READINGS OF 14.2 MMOL/L AND 13.8 MMOL/L WERE OBTAINED ON AN UNSPECIFIED SOURCE. NO TRANSPORT TO A HOSPITAL WAS REQUIRED. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412342 PRECISION XTRA BLOOD GLUCOSE MONITORING SYSTEM NBW

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R