BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE FREEDOM

    MDR report key: 1525765 · Received November 12, 2009

    Report

    Report Number
    2954323-2009-01998
    Event Type
    Malfunction
    Date Received
    November 12, 2009
    Date of Event
    October 27, 2009
    Report Date
    January 7, 2010
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER'S METER (B) (4) AND STRIP LOT 0921804 WERE RETURNED FOR INVESTIGATION. 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. THE READINGS THE CUSTOMER REPORTED WERE FOUND IN THE METER'S MEMORY.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE FILED ONCE INVESTIGATION RESULTS ARE AVAILABLE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON THEIR ADC BLOOD GLUCOSE METER. CUSTOMER REPORTED RECEIVING READINGS OF 37 MG/DL, 213 MG/DL, AND 45 MG/DL WITHIN 10 MINUTES. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL INTO THE "C" ZONE SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    MY MOM WENT INTO HOSPITAL FOR HERNIA REPAIR WITH ATRIUM C-QUR MESH. TWO WEEKS LATER, SHE STARTED SEVERELY VOMITING. WE TOOK HER TO ER MIDNIGHT IN 2009, WHERE SHE WAS ADMITTED WITH AN ABSCESS ON HER ABDOMINAL WALL WHERE THE HERNIA REPAIR TOOK PLACE. SHE HAD SURGERY WITHIN 24 HOURS AND A JP VALVE WAS PUT IN PLACE TO DRAIN THE ABSCESS. TWO DAYS LATER, WE WERE TOLD THAT THE CULTURE DONE WAS AN INFECTION. SHE WAS THEN CHANGED FROM TIGECYCLINE TO VANCOMYCIN TO CUBICIN. TODAY IS 2010 AND SHE IS NOW ON CUBICIN ANTIBIOTICS. WHITE COUNT DOWN TO 13,000 BUT SHE IS RECEIVING A BLOOD TRANSFUSION TODAY DUE RED COUNT LOW. DOCTORS SAYS, LAST RESORT IS THE MESH INFECTED. DATES OF USE: 2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FREEDOM BLOOD GLUCOSE MONITORING SYSTEM NBW 0921804

    Patients

    Seq Age Sex Outcome Treatment
    1