BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 3873214 · Received June 13, 2014

    Report

    Report Number
    2954323-2014-00661
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    May 11, 2014
    Report Date
    May 22, 2014
    Product Code
    NBW
    PMA / PMN Number
    K092602
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

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

    Additional Manufacturer Narrative · 1

    ADDITIONAL EVALUATION - METHOD: 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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT ON (B)(6) 2014 AT APPROXIMATELY 12:00PM, HE OBTAINED A READING OF 96 MG/DL ON HIS ADC BLOOD GLUCOSE METER, WHICH HE PERCEIVED TO BE LOW. CUSTOMER FURTHER REPORTED THAT ON THE MORNING OF (B)(6) 2014 HE EXPERIENCED SYMPTOMS DESCRIBED AS "SHAKINESS, EXTREME LIGHTHEADEDNESS, CAN BARELY WALK, LOSS OF APPETITE, AND VOMITING BLOOD". CUSTOMER REPORTED HE SELF-TREATED BY EATING A SANDWICH AND WAS ADMITTED INTO A LOCAL HOSPITAL BEFORE 10:00AM ON THE SAME DAY. CUSTOMER WAS REPORTEDLY DIAGNOSED WITH DIABETIC KETOACIDOSIS (DKA) AND TREATED WITH "LANTUS 20 UNITS ONCE DAILY AT 10:00PM". CUSTOMER FURTHER STATED THAT HE WAS HOSPITALIZED FROM (B)(6) 2014 UNTIL (B)(6) 2014 AND MENTIONED THAT DURING HIS STAY, HE RECEIVED HCP METER READINGS CLOSE TO 170-180 MG/DL BUT COULD NOT RECALL THE EXACT READING, DATE, OR TIME. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350890 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1381028

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Hospitalization| R