BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 2160870 · Received July 13, 2011

    Report

    Report Number
    2954323-2011-03841
    Event Type
    Injury
    Date Received
    July 13, 2011
    Date of Event
    June 14, 2011
    Report Date
    August 24, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS NOT CONFIRMED. CONTROL SOLUTION TESTING WAS PERFORMED. ALL RESULTS WERE WITHIN RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED. NO NEW ISSUES WERE OBSERVED.

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. THE PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. THE DATE OF MANUFACTURE FOR (B)(4) IS 11/24/2010. ADDITIONALLY, DURING A FOLLOW-UP CALL TO THE CUSTOMER TO GATHER ADDITIONAL INFORMATION IT WAS REVEALED THE CUSTOMER EXPERIENCED A MYOCARDIAL INFARCTION ON (B)(6) 2011 AND DIED.

    Description of Event or Problem · 1

    CUSTOMER CALLED ON (B)(6) 2011 TO INQUIRE AS TO THE NORMAL TEMPERATURE RANGE OF HER FREESTYLE FREEDOM LITE BLOOD GLUCOSE METERS AND TEST STRIPS AND NOTED SHE WAS CONCERNED BECAUSE IT HAD BEEN VERY HOT ("UP TO 100 DEGREES") RECENTLY. WHILE ON THE PHONE, CUSTOMER REPORTED THE FOLLOWING INFORMATION: ON (B)(6) 2011 CUSTOMER REPORTED BOTH HER FS FREEDOM LITE BLOOD GLUCOSE METERS WERE NOT WORKING DUE TO A TEST DOES NOT START ISSUE, WHICH PREVENTED HER FROM TESTING. CUSTOMER SELF-TREATED WITH HER ROUTINE INSULIN ORDERS OF 40 UNITS AM, 35 UNITS AT LUNCH AND 30 UNITS AT DINNER. SHE FURTHER REPORTED EXPERIENCING NAUSEA, DIAPHORESIS AND FELT "CRUDDY". AT APPROXIMATELY 9:00 PM CUSTOMER'S HUSBAND TRANSPORTED CUSTOMER TO A LOCAL EMERGENCY ROOM WHERE SHE WAS DIAGNOSED WITH DKA (DIABETIC KETOACIDOSIS) AND TREATED WITH AN UNKNOWN AMOUNT OF INSULIN, IN ADDITION TO UNSPECIFIED ANTIBIOTICS TO TREAT "AN INFECTION". CUSTOMER REPORTED RECEIVING TWO GLUCOSE RESULTS, 40 MG/DL AND 400 MG/DL, BUT IT IS UNKNOWN WHEN THESE READINGS WERE OBTAINED. 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 FREEDOM LITE BLOOD GLUCOSE MONITORING SYSTEM NBW

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R