BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE

    MDR report key: 1944858 · Received January 3, 2011

    Report

    Report Number
    2954323-2011-00001
    Event Type
    Injury
    Date Received
    January 3, 2011
    Date of Event
    December 6, 2010
    Report Date
    January 28, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S METER WAS RETURNED AND INVESTIGATED. THE COMPLAINT WAS NOT CONFIRMED AND NO NEW ISSUES WERE OBSERVED DURING CONTROL SOLUTION TESTING. THIS IS A FINAL REPORT.

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. THE CUSTOMER'S PRODUCTS HAVE BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. THE DATE OF MANUFACTURE OF THE FREESTYLE FREEDOM METER IS 12/21/2006. THE DETAILS OF THE "OTHER" LOSS OF CONSCIOUSNESS ARE UNKNOWN. CUSTOMER WAS UNABLE TO PROVIDE ANY INFORMATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT IN (B)(6) 2010, HE RECEIVED A NEW METER AND TEST STRIPS FROM LIBERTY MEDICAL. CUSTOMER REPORTED HE RECEIVED A FREESTYLE FREEDOM BLOOD GLUCOSE METER (B)(4) AND FREESTYLE LITE TEST STRIPS (LOT NO: 1026019). IT WAS FURTHER REPORTED HE NO LONGER HAS THE FREESTYLE LITE TEST STRIPS HE RECEIVED BECAUSE HE USED THEM UP. (B)(6) CONTINUED TO SEND HIM FREESTYLE LITE TEST STRIPS AND THE CUSTOMER USED THEM IN BOTH HIS FREESTYLE FREEDOM METER AND HIS FREESTYLE CLASSIC METER (B)(4). HE HAS BEEN REGULATING HIS INSULIN BASED ON THE READINGS HE HAS BEEN RECEIVING. CUSTOMER FURTHER REPORTED HE EXPERIENCED A LOSS OF CONSCIOUSNESS, "ON A COUPLE OF OCCASIONS" BECAUSE OF LOW BLOOD SUGAR. CUSTOMER NOTED THAT ONE OF THE EVENTS OCCURRED "AROUND (B)(6) 2010". CUSTOMER NOTED HE PASSED OUT AND FELL FROM HIS CHAIR ONTO THE FLOOR. HIS BLOOD SUGAR WAS TAKEN AND A RESULT OF 33 MG/DL WAS RECEIVED. HOWEVER, IT IS UNKNOWN WHICH METER WAS USED OR THE EXACT DATE AND TIME THE READING WAS RECEIVED. NO THIRD-PARTY EMERGENT MEDICAL INTERVENTION WAS REPORTED. CUSTOMER SELF-TREATED BY INGESTING AND UNKNOWN NUMBER OF "GLUCOSE PILLS", DRANK ORANGE JUICE AND ATE FOOD. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM NBW 1026019

    Patients

    Seq Age Sex Outcome Treatment
    1 Other