BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE LITE

    MDR report key: 1569164 · Received January 4, 2010

    Report

    Report Number
    2954323-2010-00004
    Event Type
    Malfunction
    Date Received
    January 4, 2010
    Date of Event
    December 27, 2009
    Report Date
    April 29, 2010
    Product Code
    NBW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. THE DEVICES HAVE BEEN REQUESTED BACK FOR INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. IT SHOULD BE NOTED: THE TEST STRIPS USED WITH FREESTYLE LITE BLOOD GLUCOSE METERS CONTAIN GDH-PQQ, HENCE, THEY ARE SUSCEPTIBLE TO INTERFERENCE FROM PRODUCTS CONTAINING NON-GLUCOSE SUGARS SUCH AS MALTOSE, GALACTOSE AND XYLOSE. CUSTOMER REPORTED THAT HE WAS RECEIVING THERAPY WITH NON-GLUCOSE SUGARS, BUT DID NOT ELABORATE. ATTEMPTS HAVE BEEN MADE TO CONTACT THE CUSTOMER TO GATHER ADDITIONAL INFORMATION REGARDING THIS EVENT. IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    (B) (4). CUSTOMERS METER SN ((B) (4)) WAS RETURNED AND INVESTIGATED. 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. TWO OF THE READINGS THE CUSTOMER REPORTED WERE FOUND IN METER'S MEMORY HOWEVER, THEY WERE OBTAINED OUTSIDE THE TEN MINUTE TIMEFRAME. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 76.7 MONTHS, DUE TO UNKNOWN REASONS. NO FURTHER DETAILS WERE PROVIDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON HIS FREESTYLE LITE BLOOD GLUCOSE METER. CUSTOMER REPORTED RECEIVING READINGS OF 11.2 MMOL/L (202 MG/DL), 11.5 MMOL/L (207 MG/DL) AND 1.4 MMOL/L (25 MG/DL) WITHIN 10 MINUTES. ALL TESTS WERE PERFORMED ON THE FINGER. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL INTO THE "C" ZONE SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT. CUSTOMER FURTHER REPORTED EXPERIENCING A LOSS OF CONSCIOUSNESS, A SEIZURE, A "STROKE" AND CHEST PAIN. PARAMEDICS WERE CALLED AND THEY TRANSPORTED CUSTOMER TO A LOCAL HEALTHCARE FACILITY, WHERE HE WAS DIAGNOSED WITH HYPOGLYCEMIA. CUSTOMER NOTED HE COULD NOT REMEMBER ALL THE TREATMENT HE WAS GIVEN, BUT THOUGHT HE HAD RECEIVED A GLUCAGON/DEXTROSE INJECTION. CUSTOMER ADDITIONALLY REPORTED SELF-TREATING WITH LANTUS INSULIN, A RAPID-ACTING INSULIN (NOVO RAPID) AND GLUCAGON, WHICH HE STATED WAS NOT A CHANGE TO HIS USUAL MEDICATIONS. 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 LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 0925936

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention