BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE FLASH

    MDR report key: 1800195 · Received August 29, 2007

    Report

    Report Number
    2954323-2007-15879
    Event Type
    Malfunction
    Date Received
    August 29, 2007
    Date of Event
    June 21, 2007
    Report Date
    August 29, 2007
    Manufacturer
    ABBOTT DIABETES CARE INC, USA
    Product Code
    LFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE METER HAS BEEN CONFIRMED TO EXHIBIT THE MEMORY OVERWRITE MALFUNCTION. CUSTOMERS AND RETAILERS HAVE BEEN INFORMED THROUGH THE FA16MAY2006 LETTER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN ISSUE WITH METER. UPON INVESTIGATION, THE METER WAS FOUND TO EXHIBIT THE MEMORY OVERWRITE MALFUNCTION. THERE WAS NO REPORT OF DEATH OR SERIOUS INJURY. HOWEVER, IT SHOULD BE NOTED THE CUSTOMER REPORTED RECEIVING A READING HIGHER THAN SHE FELT. SHE GAVE HERSELF MORE INSULIN WHICH RESULTED IN SYMPTOMS OF HYPOGLYCEMIA INCLUDING DIAPHORESIS, SHAKING AND NAUSEA. SHE DRANK ORANGE JUICE AND ATE CRACKERS TO TREAT HER SYMPTOMS. SHE DID NOT REQUIRE THIRD PARTY MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FLASH BLOOD GLUCOSE MONITORING SYSTEM LFR ABBOTT DIABETES CARE INC, USA NI 0633132

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK