BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION XTRA

    MDR report key: 3233044 · Received July 18, 2013

    Report

    Report Number
    2954323-2013-00387
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 14, 2013
    Report Date
    June 23, 2013
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER RETURNED METER SERIAL NUMBER ((B)(4)). THE RETURNED METER WAS INVESTIGATED WITH RETURNED TEST STRIPS (4(B)(4)). 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. A SIMILAR READING OF 157 MG/DL WAS FOUND IN THE METER MEMORY LOG ON THE DAY OF THE REPORTED MEDICAL EVENT.

    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 METER SERIAL NUMBER IS UNKNOWN, THEREFORE, THE DEVICE MANUFACTURE DATE IS UNKNOWN. THE DEVICE MANUFACTURE DATE ENTERED IS THE COMPLAINT AWARENESS DATE. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    CALLER (CUSTOMER'S DAUGHTER) REPORTED THAT ON (B)(6) 2013 AT APPROXIMATELY 8:00 A.M., THE CUSTOMER WAS FOUND UNCONSCIOUS AND UNRESPONSIVE. A BLOOD GLUCOSE TEST WAS PERFORMED ON THE CUSTOMER AND A READING OF 151 MG/DL WAS OBTAINED. IT IS UNKNOWN WHAT, IF ANY, SELF-TREATMENT WAS PERFORMED. PARAMEDICS WERE CALLED AND A READING OF 22 MG/DL WAS OBTAINED ON THEIR UNKNOWN BRAND OF METER. CUSTOMER WAS TREATED ON THE SCENE WITH GLUCOSE VIA INTRAVENOUS INFUSION AND TRANSPORTED TO A LOCAL HEALTHCARE FACILITY. CUSTOMER WAS DIAGNOSED WITH HYPOGLYCEMIA AND A URINARY TRACT INFECTION. CUSTOMER WAS TREATED WITH ADDITIONAL INTRAVENOUS GLUCOSE, UNSPECIFIED INTRAVENOUS MEDICATIONS AND A FEEDING TUBE. CUSTOMER WAS ALSO GIVEN CIPRO (CIPROFLOXACIN), AN ANTIBIOTIC FOR HIS URINARY TRACT INFECTION. THERE WAS NO REPORT OF DEATH, PERMANENT INJURY OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334682 PRECISION XTRA BLOOD GLUCOSE MONITORING SYSTEM NBW 4500161240

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Hospitalization| O| R