BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE

    MDR report key: 4090519 · Received September 15, 2014

    Report

    Report Number
    2954323-2014-00965
    Event Type
    Injury
    Date Received
    September 15, 2014
    Date of Event
    August 19, 2014
    Report Date
    August 20, 2014
    Product Code
    LFR
    PMA / PMN Number
    K092638
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A FINAL REPORT. THE REPORTED TEST STRIPS WERE RETURNED AND INVESTIGATED WITH A RETAINED METER. 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. 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 APPROXIMATELY 7:12 P.M., WHILE HAVING DINNER AT A RESTAURANT, SHE EXPERIENCED SYMPTOMS DESCRIBED AS "DIZZINESS, LIGHTHEADED, INABILITY TO EAT AND DRINK, INCOHERENCE" AND STATED SHE "PASSED OUT". CUSTOMER FURTHER REPORTED THAT AT 7:17 P.M. HER HUSBAND OBTAINED A READING OF 82 MG/DL ON HER OMNIPOD SYSTEM WITH ADC TEST STRIPS. A NURSE IN THE RESTAURANT GAVE THE CUSTOMER "ORANGE JUICE WITH SUGAR" AND THEN THE PARAMEDICS WERE CALLED. UPON THEIR ARRIVAL, THE PARAMEDICS TESTED THE CUSTOMER'S BLOOD PRESSURE AND BLOOD GLUCOSE AND A READING OF 15 MG/DL WAS OBTAINED ON THE HCP METER. CUSTOMER WAS REPORTEDLY TREATED WITH "4 DIFFERENT VIALS OF GLUCOSE VIA ARTERY" AND A SUBSEQUENT HCP METER READING OF 250 MG/DL WAS OBTAINED. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570244 FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM LFR 1454357

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other| R