BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 3233841 · Received July 18, 2013

    Report

    Report Number
    2954323-2013-00388
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 20, 2013
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED. THE METER WAS RETURNED AND AN INVESTIGATION UTILIZING THE RETURNED METER, RETURNED TEST STRIPS AND RETAINED CONTROL SOLUTION (LOT 2F3U05) HAS DETERMINED THE COMPLAINT IS NOT CONFIRMED. ALL RESULTS WERE WITHIN RANGE SPECIFICATION. IT SHOULD BE NOTED THAT WHILE CUSTOMER REPORTED HAVING AN ER-4 MESSAGE ON (B)(6) 2013, ACCORDING TO RETURNED METER'S MEMORY LOG THE CUSTOMER DID NOT TEST IN 2013.

    Description of Event or Problem · 1

    CALLER REPORTED THAT CUSTOMER (HER HUSBAND) EXPERIENCED SYMPTOMS DESCRIBED AS "SICKNESS, TIRED, CLAW HAND" AND "THOUGHT (THESE) WERE SYMPTOMS OF STROKE (HE) HAD PREVIOUSLY". IT WAS FURTHER REPORTED THAT CUSTOMER CALLED HIS HCP AND WAS ADVISED TO CHECK HIS BLOOD GLUCOSE READING. WHEN CUSTOMER ATTEMPTED TO TEST HE WAS UNABLE TO OBTAIN HIS BLOOD GLUCOSE READING DUE TO RECEIVING AN ER-4 MESSAGE ON HIS ADC METER. PARAMEDICS WERE CALLED AND TRANSPORTED CUSTOMER TO A LOCAL HEALTH CARE FACILITY. CUSTOMER'S WIFE REPORTED THAT AT A LOCAL HEALTH CARE FACILITY A BLOOD GLUCOSE READING OF 20.5 MMOL/L (369 MG/DL) AND A KETONE READING OF 1.9 MMOL/L WERE OBTAINED (THE METHOD IS UNKNOWN) AND CUSTOMER WAS DIAGNOSED WITH HYPERGLYCEMIA. IT IS UNKNOWN, WHAT TYPE, IF ANY, TREATMENT WAS GIVEN. 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
    333013 FREESTYLE FREEDOM LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1250521

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization