BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE LITE

    MDR report key: 1826222 · Received September 3, 2010

    Report

    Report Number
    2954323-2010-01236
    Event Type
    Malfunction
    Date Received
    September 3, 2010
    Date of Event
    August 5, 2010
    Report Date
    October 5, 2010
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER'S METER AND STRIP LOT # 1014238 AS WELL AS CONTROL SOLUTION LOT #9F2J55 WERE RETURNED AND INVESTIGATED. 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. THE READING OF 19MG/DL AS REPORTED BY THE CUSTOMER WAS NOT FOUND IN METER MEMORY. THIS IS A FINAL REPORT.

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. THE CUSTOMER'S PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE FILED ONCE INVESTIGATION RESULTS ARE AVAILABLE. NOTE: DURING A FOLLOW-UP CALL CUSTOMER REMEMBERED RECEIVING A READING OF 19 MG/DL. HOWEVER, IT SHOULD BE NOTED A BLOOD GLUCOSE READING BELOW 20 MG/DL WILL GIVE A READING OF "LO" IN THE ADC METER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 18.73 MONTHS. THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER, IT WAS LEARNED THAT THE DEVICE WAS EXPLANTED DUE TO REGURGITATION, PARAVALVULAR LEAK, AND ENDOCARDITIS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING UNSPECIFIED ERRATIC READINGS FROM HIS FREESTYLE LITE METER. CUSTOMER FURTHER REPORTED SELF-ADMINISTERING HIS INSULIN MEDICATION BASED ON AN UNSPECIFIED READING AND HAVING SYMPTOMS OF HYPOGLYCEMIA. CUSTOMER REPORTED HAVING FOOD AND DRINK TO COUNTERACT HIS SYMPTOMS. CUSTOMER ALSO REPORTED SUBSEQUENTLY VISITING HIS DOCTOR WHO DIAGNOSED CUSTOMER WITH SEVERE HYPERGLYCEMIA AND TREATED CUSTOMER WITH AN IV AND INSULIN. THE TIMING BETWEEN CUSTOMER'S REPORTED SYMPTOMS AND HIS DOCTOR'S VISIT IS UNKNOWN. ADC CUSTOMER SERVICES WERE ABLE TO REACH CUSTOMER AT ONE OF THE FOLLOW-UP CALLS AND CUSTOMER STATED THAT HE DID NOT REMEMBER THE DETAILS OF THE EVENT SINCE IT HAPPENED A LONG TIME AGO. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1014238

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention