BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 1213864 · Received October 28, 2008

    Report

    Report Number
    2954323-2008-02776
    Event Type
    Injury
    Date Received
    October 28, 2008
    Date of Event
    September 27, 2008
    Report Date
    October 28, 2008
    Manufacturer
    ABBOTT DIABETES CARE INC.
    Product Code
    LFR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. PRODUCT HAS BEEN REQUESTED FOR INVESTIGATION AND A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. NOTE: THIS METER DOES NOT GIVE A NUMERICAL VALUE FOR READINGS LESS THAN 20 MG/DL. A "LO" DISPLAY MESSAGE INDICATES A METER READING LESS THAN 20 MG/DL.

    Description of Event or Problem · 1

    CUSTOMER'S FAMILY MEMBER CALLED INITIALLY TO TRAIN ON HOW TO CHANGE THE METER'S TIME. SHE REPORTED THAT THE DATE IS CORRECT, BUT THE TIME IS 2 HOURS OFF. SHE THEN REPORTED THAT IN 2008, THEIR SON WAS AT A ROUTINE DOCTOR'S VISIT AND THEIR METER'S READING LOG WAS UPLOADED AND AS A RESULT, HIS INSULIN PUMP BASAL AND BOLUS RATE WERE ADJUSTED. SHE STATED A FEW DAYS LATER(THREE DAYS LATER), HER SON HAD A SEIZURE AND LOST CONSCIOUSNESS. THEY ADMINISTERED GLUCAGON AND RECOVERED. HE DID NOT REQUIRE THIRD-PARTY MEDICAL INTERVENTION FOR THAT EVENT. SHE STATED THE FOLLOWING DAY, HER SON BEGAN FEELING WEAK WHILE WITH HIS FATHER AND HE OBTAINED A METER READING OF 78 MG/DL AND A "LO" READING A FEW MINS LATER AND THEIR SON EXPERIENCED A SEIZURE AND LOST CONSCIOUSNESS AGAIN. PARAMEDICS WERE CALLED AND ADMINISTERED GLUCAGON, SODA, GLUCOSE TABLETS AND GEL. THEY DID NOT TRANSPORT TO A LOCAL HOSPITAL AND NO DIAGNOSIS WAS REPORTED. THE CUSTOMER STATED THAT THESE EVENTS WERE DUE TO THE METER'S DATE NOT BEING SET CORRECTLY. THEY STATED THEY NEVER SET THE DATE/TIME WHEN THEY RECEIVED THE NEW METER IN THE PREVIOUS MONTH. THEY DID NOT REPORT BEING A USER OF PLINK SOFTWARE AND IT IS UNK IF THE CUSTOMER'S ROUTINE HCP IS A USER OF PLINK SOFTWARE. IN ADDITION, THE CUSTOMER REPORTED THAT THE PARAMEDIC'S HCP METER READING RECEIVED ON FOUR DAYS AFTER ORIGINAL DATE WAS "100 POINTS HIGHER" THAN THE FS LITE METER'S READINGS, HOWEVER, BOTH READINGS WERE NOT REPORTED. THIS TYPE OF READING COMPARISON IS AN INVALID METHOD. ATTEMPTS HAVE BEEN MADE TO CLARIFY THE MEDICAL EVENT AND READING ISSUES. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THESE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM LFR ABBOTT DIABETES CARE INC. NI 0812735

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention