BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 1933524 · Received December 20, 2010

    Report

    Report Number
    2954323-2010-01698
    Event Type
    Injury
    Date Received
    December 20, 2010
    Date of Event
    December 3, 2010
    Report Date
    February 9, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS NOT CONFIRMED AND NO NEW ISSUES WERE OBSERVED. ALL FUNCTIONAL TEST RESULTS WERE WITHIN RANGE SPECIFICATION. NO ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING. THIS IS A FINAL REPORT.

    Additional Manufacturer Narrative · 1

    AS THE SPECIFIC DATE OF EVENT IS NOT KNOWN. CUSTOMER'S PRODUCT HAS BEEN REQUESTED BACK FOR INVESTIGATION AND A SUPPLEMENTAL REPORT WILL BE SENT ONCE NEW INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    A USER REPORT FROM THE AEMPS WAS RECEIVED REGARDING A MEDICAL EVENT THAT INVOLVED THE USE OF AN ADC METER. THE REPORT STATED AN ADC CUSTOMER REPORTED THAT IN (B)(4) 2010 (SPECIFIC DATE UNKNOWN) THEY HAD EXPERIENCED SYMPTOMS OF HYPOGLYCEMIA YET SEVERAL READINGS OVER 100MG/DL WERE REPORTEDLY OBTAINED ON THEIR FS LITE METER. THE SPECIFIC READINGS OR TIME THESE READINGS WERE OBTAINED IN RELATION TO THE REPORTED MEDICAL EVENT IS UNKNOWN. THE CUSTOMER FURTHER REPORTED THAT PARAMEDICS AND AN EMERGENCY HELICOPTER WERE REQUIRED TO TRANSPORT THE CUSTOMER TO A LOCAL HEALTH CARE FACILITY. THE CUSTOMER WAS DIAGNOSED WITH HYPOGLYCEMIA, TREATED WITH MEDICATIONS AND REPORTEDLY RECOVERED HOWEVER, THE SPECIFIC MEDICATIONS WERE NOT REPORTED. IT IS UNKNOWN IF THE CUSTOMER EXPERIENCED A LOSS OF CONSCIOUSNESS OR SEIZURE ACTIVITY. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 0811419

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention