BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FLASH

    MDR report key: 582549 · Received March 17, 2005

    Report

    Report Number
    2954323-2005-00075
    Event Type
    Injury
    Date Received
    March 17, 2005
    Date of Event
    February 22, 2005
    Report Date
    March 17, 2005
    Manufacturer
    THERASENSE INC.
    Product Code
    LFR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER WAS ASLEEP AND UNRESPONSIVE. THEY REQUESTED WATER AND WAS AGITATED. READINGS OF 117, 161, 156, 183, 117 AND 170 MG/DL WERE RECEIVED WITH THE FREESTYLE FLASH. COMPARISON READINGS WERE TAKEN WITH A FREESTYLE METER WITH RESULTS OF 59, 61, 56, 70, 45 MG/DL. PARAMEDICS WERE CALLED AND PT WAS TRANSPORTED TO THE HOSP. DEXTROSE TREATMENT WAS PROVIDED AT THE HOSP. PT WAS READMITTED TO THE HOSP AFTER EMERGENCY ROOM TREATMENT AS THEY WENT INTO SHOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FLASH BLOOD GLUCOSE MONITORING SYSTEM LFR THERASENSE INC. * 0418159

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Hospitalization| R LANTUS 5 UNITS AND HUMALOG AS NEEDED ON A SLIDING| SCALE.