BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 1836611 · Received September 16, 2010

    Report

    Report Number
    2954323-2010-01286
    Event Type
    Injury
    Date Received
    September 16, 2010
    Date of Event
    August 23, 2010
    Report Date
    November 19, 2010
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REQUESTED PRODUCT WAS NOT RECEIVED FOR INVESTIGATION. RETAINED TEST STRIP SAMPLES FROM THE SAME LOT REPORTED BY THE CUSTOMER (1010640) 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.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. NOTE: REGARDING THE READINGS RECEIVED WITHIN TEN MINUTES (400 MG/DL, 306 MG/DL AND 209 MG/DL), RESULTS WERE PLOTTED ON A PARKES ERROR GRID AND FELL INTO THE "B" ZONE SHOWING THE DIFFERENCE IN VALUES WAS NOT CLINICALLY SIGNIFICANT.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT ON (B)(6)-2010, APPROXIMATELY AT 9:44 PM, HE RECEIVED THE FOLLOWING READINGS ON HIS FREESTYLE LITE BLOOD GLUCOSE METER WITHIN TEN MINUTES: 400 MG/DL, 306 MG/DL AND 209 MG/DL. THE CUSTOMER ALSO REPORTED THAT ON (B)(6)-2010, APPROXIMATELY AT 5:00 AM, HE LOST CONSCIOUSNESS TWICE (HE DID NOT RECALL ANY OTHER SYMPTOM) DUE TO NOT RECEIVING THE "RIGHT READINGS". THE PARAMEDICS WERE CALLED, OBTAINED A READING OF 35 MG/DL (DEVICE USED IS UNKNOWN) AND TREATED HIM WITH "SOME FLUID" TO BRING HIS BLOOD GLUCOSE UP. ALTHOUGH THE CUSTOMER REPORTED HE WAS TRANSPORTED TO A HEALTH CARE FACILITY, DIAGNOSED WITH HYPOGLYCEMIA, HE DID NOT KNOW THE MEDICAL TREATMENT PROVIDED. THE CUSTOMER ALSO REPORTED HE DRANK A GLASS OF MILK TO ALLEVIATE HIS SYMPTOMS. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    REPORTER ALLEGED THAT THE CUSTOMER WAS USING THE MULTICLIX LANCET DEVICE ONLY ON HER RIGHT HAND AND SOON AFTER, SHE STARTED TO HAVE PAIN. REPORTER STATED THAT SOME TIME AFTER THAT, THE RIGHT HAND STARTED TO SWELL AND THEY SOUGHT MEDICAL TREATMENT. REPORTER STATED THE CUSTOMER WAS PUT ON A HIGH POTENT ANTIBIOTIC TO TREAT HER FOR EITHER BLOOD POISONING OR AN INFECTION THOUGHT TO BE CAUSED BY THE LANCET NEEDLE IN THE DEVICE. NO OTHER ACTION OR TREATMENT RESULTED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1010640

    Patients

    Seq Age Sex Outcome Treatment
    1 Other