BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 2353401 · Received November 30, 2011

    Report

    Report Number
    2954323-2011-05257
    Event Type
    Injury
    Date Received
    November 30, 2011
    Date of Event
    October 28, 2011
    Report Date
    February 9, 2012
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. THE PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS AVAILABLE.

    Additional Manufacturer Narrative · 1

    AS PRODUCT WAS NOT RETURNED AND NO TEST STRIP LOT WAS REPORTED WITH THIS COMPLAINT, A DEVICE HISTORY REVIEW (DHR) OF THE METER WAS REQUESTED. THE DHR FOR METER SERIAL NUMBER (B)(4) INDICATED THE DEVICE WAS PERFORMING WITHIN ITS PERFORMANCE CLAIMS AND MET THE MANUFACTURER'S QUALITY SPECIFICATIONS PRIOR TO ITS RELEASE. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE PACKAGE CONTAINING HIS FREESTYLE FREEDOM LITE METER HAD A BROKEN SEAL, AND THAT THE LANCING DEVICE WAS MISSING. THE CUSTOMER REPORTED THAT ON (B)(6) 2011, HE WAS EXPERIENCING SYMPTOMS OF "SWEATING", AND THEN WENT INTO THE BATHROOM TO TEST USING THE LANCET WITHOUT THE LANCING DEVICE. THE CUSTOMER REPORTED HE OBTAINED A TEST RESULT "IN THE 200'S". THE CUSTOMER STATED HE "THEN PRESSED THE HELP BUTTON AND BY THE TIME THE NURSES CAME TO HIM HE WAS HAVING A SEIZURE ON THE BATHROOM FLOOR." (THE CUSTOMER HAS A HOME-HEALTH NURSE.) THE CUSTOMER STATED HE EXPERIENCED A SEIZURE AND A LOSS OF CONSCIOUSNESS. HE REPORTED HE "BRIEFLY REMEMBERS GETTING SOME TYPE OF MEDICINE UP HIS NOSE." PARAMEDICS WERE CALLED AND HE WAS TRANSPORTED TO A HEALTH CARE FACILITY. THE CUSTOMER DID NOT KNOW WHAT DIAGNOSES HE WAS GIVEN. HE DID NOT KNOW THE NAME OF THE MEDICATION HE WAS TREATED WITH, BUT STATED "IT WAS LIKE TOOTHPASTE "(GLUCOSE GEL). NO READINGS WERE PROVIDED FROM THE HEALTH CARE FACILITY. THE CUSTOMER REPORTED SELF-TREATMENT WITH ORANGE JUICE. THERE IS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other