BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 2723762 · Received September 1, 2012

    Report

    Report Number
    2954323-2012-06536
    Event Type
    Injury
    Date Received
    September 1, 2012
    Date of Event
    August 9, 2012
    Report Date
    August 11, 2012
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REQUESTED PRODUCT WAS NOT RECEIVED FOR INVESTIGATION. RETAINED TEST STRIP SAMPLES FROM THE SAME LOT REPORTED BY THE CUSTOMER (1160961) WERE TESTED WITH CONTROL SOLUTION INSTEAD. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED. THE COMPLAINT IS NOT CONFIRMED.

    Additional Manufacturer Narrative · 1

    THE PRODUCTS HAVE BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED BEING UNABLE TO TEST DUE TO RECEIVING UNSPECIFIED ERROR MESSAGE ON HIS ADC METER. CUSTOMER FURTHER REPORTED THAT "THIS (ISSUE) HAPPENED ABOUT SIX WEEKS AGO AND (HE) HA(D) NOT BEEN TESTING" AND AS A RESULT ON (B)(6) 2012 EXPERIENCED SYMPTOMS THAT WERE DESCRIBED AS "DIZZY WITH A HEADACHE" AND HAD A LOSS OF CONSCIOUSNESS. CUSTOMER DENIED SELF-TREATMENT. PARAMEDICS WERE CALLED, A READING OF 35 MG/DL WAS OBTAINED ON UNSPECIFIED HCP METER, CUSTOMER WAS ADMINISTERED GLUCOSE ORALLY AND THEN A READING OF 46 MG/DL WAS OBTAINED ON UNSPECIFIED HCP METER. IT WAS FURTHER REPORTED THAT CUSTOMER WAS TRANSPORTED TO A LOCAL HEALTH CARE FACILITY WHERE HE WAS TREATED WITH GLUCOSE VIA INTRAVENOUS INFUSION AND WAS GIVEN SOMETHING TO EAT. CUSTOMER HAD HIS BLOOD GLUCOSE LEVEL MONITORED EVERY HOUR UNTIL HE WAS DISCHARGED. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FREEDOM LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1160961

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other| R