BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 1720660 · Received June 11, 2010

    Report

    Report Number
    2954323-2010-00798
    Event Type
    Injury
    Date Received
    June 11, 2010
    Date of Event
    May 20, 2010
    Report Date
    October 19, 2010
    Product Code
    NBW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE PRODUCT IS RETURNED AND INVESTIGATION IS COMPLETE. THE CUSTOMER'S PRODUCT HAS BEEN REPLACED WITH A PRECISION BLOOD GLUCOSE METER AND TEST STRIPS THAT ARE NOT SUSCEPTIBLE TO INTERFERENCE WITH GDH-PQQ (GLUCOSE DEHYDROGENASE PYRROLOQUINOLINE QUINONE). NOTE: FALSELY ELEVATED BLOOD GLUCOSE RESULTS CAN OCCUR WHEN USING GDH-PQQ (GLUCOSE DEHYDROGENASE PYRROLOQUINOLINE QUINONE) GLUCOSE TEST STRIPS WITH PATIENTS WHO ARE RECEIVING THERAPEUTIC PRODUCTS CONTAINING NON-GLUCOSE SUGARS SUCH AS EXTRANEAL (ICODEXTRIN) PERITONEAL DIALYSIS SOLUTION.

    Additional Manufacturer Narrative · 1

    REQUESTED PRODUCT WAS NOT RECEIVED FOR INVESTIGATION. RETAINED TEST STRIP SAMPLES FROM THE SAME LOT REPORTED BY THE CUSTOMER (B)(4) WERE TESTED WITH CONTROL SOLUTION INSTEAD. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED. THE COMPLAINT IS NOT CONFIRMED. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED SHE COMPARED A READING OF 210 MG/DL OBTAINED ON HER FREESTYLE FREEDOM LITE BLOOD GLUCOSE METER TO LAB RESULT OF 48 MG/DL. THE RESULTS WERE PLOTTED ON A PARKES ERROR GRID AND FELL INTO THE "D" ZONE SHOWING THE DIFFERENCE IN VALUES WAS CLINICALLY SIGNIFICANT. THE CUSTOMER ADDITIONALLY REPORTED SHE WAS A PERITONEAL DIALYSIS PATIENT USING EXTRANEAL (ICODEXTRIN) PERITONEAL DIALYSIS SOLUTION. THE CUSTOMER REPORTEDLY EXPERIENCED A MEDICAL EVENT WHEN SHE LOST CONSCIOUSNESS. THE PARAMEDICS WERE CALLED AND SHE REPORTED BEING TREATED WITH AN INTRAVENOUS MEDICATION AND ICODEXTRIN. THE CUSTOMER ALSO REPORTED DRINKING JUICE TO ALLEVIATE HER SYMPTOMS AND SHE WAS NOT TRANSPORTED TO A MEDICAL FACILITY. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT, THE DOCTOR WAS UNABLE TO ACCESS THE VESSEL IN ORDER TO PLACE THE 4196 LEAD FOR THE PLANNED BI-VENTRICULAR UPGRADE. THE LEAD WAS NOT USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FREEDOM LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 0916132

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R