BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 1792140 · Received August 10, 2010

    Report

    Report Number
    2954323-2010-01095
    Event Type
    Injury
    Date Received
    August 10, 2010
    Date of Event
    July 17, 2010
    Report Date
    August 10, 2010
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER'S METER ((B)(4)) HAS BEEN RETURNED TO THE LAB AND PRODUCT TESTING DID NOT CONFIRM THE READINGS COMPLAINT. METER GLUCOSE READINGS (54 MG/DL ON (B)(6) AT 10:18PM AND 372 MG/DL ON (B)(6) AT 11:18PM) WERE FOUND IN THE METER'S HYPERTERMINAL; HOWEVER, THE REPORTED READINGS OF 200 MG/DL AND 40 MG/DL WERE NOT FOUND AT THE TIME OF THE REPORTED EVENT. ALL RESULTS WERE WITHIN RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING. NOTE: THE REPORTED READINGS WERE NOT TAKEN WITHIN 10 MINUTES MAKING THE READINGS INVALID FOR COMPARISON.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING ERRATIC READINGS OF 52 MG/DL (AT 10:18PM) AND 372 MG/DL (AT 11:18PM) FROM HIS FREESTYLE FREEDOM LITE METER ON (B)(6), 2010. CUSTOMER ALSO REPORTED RECEIVING A GLUCOSE READING AROUND 200 MG/DL AND ENTERED THE NUMBER INTO HIS INSULIN PUMP BEFORE GOING TO BED, THEN HIS WIFE WOKE HIM UP BECAUSE HE WAS KICKING AND DISORIENTED. CUSTOMER REPORTED ON (B)(6), 2010 AT 3:30AM, HE EXPERIENCED SYMPTOMS OF HYPOGLYCEMIA AND INCOHERENCE WITH A GLUCOSE READING OF 40 MG/DL. PARAMEDICS WERE CALLED AND THEY TREATED CUSTOMER WITH IV DEXTROSE. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FREEDOM LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1008436

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention