BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREEDOM LITE

    MDR report key: 1710562 · Received June 4, 2010

    Report

    Report Number
    2954323-2010-00758
    Event Type
    Injury
    Date Received
    June 4, 2010
    Date of Event
    May 11, 2010
    Report Date
    August 3, 2010
    Product Code
    NBW
    Adverse Event
    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.

    Additional Manufacturer Narrative · 1

    REQUESTED PRODUCT WAS NOT RECEIVED FOR INVESTIGATION. RETAINED TEST STRIP SAMPLES FROM THE SAME LOT REPORTED BY THE CUSTOMER (0932003) WERE TESTED WITH CONTROL SOLUTION INSTEAD. ALL RESULTS WERE WITHIN THE RANGE OF SPECIFICATION AND NO ERRORS WERE OBSERVED. THE COMPLAINT IS NOT CONFIRMED.

    Description of Event or Problem · 1

    THE CUSTOMER'S WIFE REPORTED THE CUSTOMER RECEIVED WITHIN TEN MINUTES THE FOLLOWING READINGS ON HIS FREESTYLE FREEDOM LITE BLOOD GLUCOSE METER: 305 MG/DL AND 183 MG/DL. THE RESULTS WERE PLOTTED ON A PARKES ERROR GRID AND FELL INTO THE "B" ZONE SHOWING THE DIFFERENCE IN VALUES WAS NOT CLINICALLY SIGNIFICANT. THE CUSTOMER'S WIFE ADDITIONALLY REPORTED THAT THE CUSTOMER WENT TO A MOBILE INFIRMARY "AS A RESULT OF NOT BEING ABLE TO ACCURATELY TEST ON THE ADC METER". THE CUSTOMER'S WIFE WAS REPORTEDLY UNABLE TO ANSWER ANY FURTHER TROUBLESHOOTING SURVEY QUESTIONS AS SHE REPORTED THE CUSTOMER WAS SICK AND SHE COULD NOT REMAIN ON THE PHONE. CUSTOMER SERVICE MADE ATTEMPTS TO CONTACT THE CUSTOMER LATER TO COMPLETE THE SURVEY QUESTIONS, BUT THE CUSTOMER COULD NOT BE REACHED. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    A PATIENT REPORTED BLOOD GLUCOSE RESULTS OF "29 MG/DL", "140 MG/DL" AND "135MG/DL" WITH A LIFESCAN METER AND "170 MG/DL" ON ANOTHER METER, PERFORMED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <= 30% AND/OR <= 30 MG/DL. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WERE NO ALLEGATIONS OF HARM OR INJURY. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREEDOM LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 0932003

    Patients

    Seq Age Sex Outcome Treatment
    1 Other