BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 2216736 · Received August 18, 2011

    Report

    Report Number
    2954323-2011-04243
    Event Type
    Injury
    Date Received
    August 18, 2011
    Date of Event
    July 19, 2011
    Report Date
    October 19, 2011
    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. IT SHOULD BE NOTED THAT THE TEST STRIPS WERE EXPIRED AND INCOMPATIBLE WITH THE FREESTYLE LITE METER (LOT # 0832003, FREESTYLE CLASSIC TEST STRIPS, EXP. NOV 2010).

    Additional Manufacturer Narrative · 1

    AS PRODUCT WAS NOT RETURNED AND TEST STRIP LOT REPORTED WITH THIS COMPLAINT IS EXPIRED, A DEVICE HISTORY REVIEW (DHR) OF THE REPORTED METER WAS REQUESTED INSTEAD. THE DHR FOR METER (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

    ON (B)(6) 2011 A CUSTOMER REPORTED SHE RECEIVED "INCORRECT" TEST STRIPS IN THE SEALED METER KIT FOR THE NEW FREESTYLE LITE GLUCOSE METER SHE OBTAINED AT A PHARMACY. THE CUSTOMER REPORTED "FOR AROUND 2-3 WEEKS, SHE HAD BEEN EATING AND TAKING HER NORMAL MEDICATIONS IN THE MORNINGS, BUT WAS UNABLE TO TEST HER SUGAR LEVEL." THE CUSTOMER STATED AROUND THE (B)(6) SHE EXPERIENCED "EXTREME DIZZINESS, SHE COULDN'T SEE BECAUSE HER EYES WERE BLURRY, AND SHE FELL BRUISING HER KNEE." THE CUSTOMER'S SON TRANSPORTED HER TO A HEALTH CARE FACILITY WHERE SHE WAS DIAGNOSED WITH HYPERGLYCEMIA. THE CUSTOMER STATED "THE DOCTOR AT THE HOSPITAL TOLD HER THE EXPERIENCE WHICH SENT HER THERE THAT DAY WAS THE BEGINNING OF A HEART FAILURE." SHE FURTHER REPORTED "THE DOCTORS WERE CONCERNED ABOUT HER HEART AND TRANSPORTED HER TO (B)(6) HOSPITAL TO CHECK HER HEART. THEY GAVE HER AN IV AND TRIED TO TEST HER SUGAR BY DOING A FINGER STICK TEST, BUT THEIR METER ONLY READ HIGH AND THEY HAD TO DO A LAB TEST. WHEN THE REPORT CAME BACK LATER THEY SAID HER SUGAR WAS AROUND 550, ALMOST AT THE 600 MARK." THE CUSTOMER DID NOT PROVIDE ANY INFORMATION REGARDING TREATMENT OF HER HYPERGLYCEMIA. THERE IS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 0832003

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention