BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FLASH

    MDR report key: 1919925 · Received December 10, 2010

    Report

    Report Number
    2954323-2010-01664
    Event Type
    Injury
    Date Received
    December 10, 2010
    Date of Event
    November 15, 2010
    Report Date
    March 24, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER WITH SERIAL NUMBER (B)(4) WAS RETURNED AND AN INVESTIGATION UTILIZING THE RETURNED METER AND RETAINED TEST STRIP LOT NO: 1001525 HAS DETERMINED THE COMPLAINT IS CONFIRMED. METER DID NOT POWER ON WITH BUTTON DEPRESSION. METER DID NOT POWER ON WITH STRIP INSERTION. BLANK SCREEN WAS OBSERVED. IT WAS ADDITIONALLY NOTED THE SOFTWARE WAS CORRUPTED. ALSO, PLEASE NOTE: ON THE ORIGINAL MDR, IT WAS REPORTED THAT THE CUSTOMER HAD NOTED A BATTERY AND BOOKLET ICON ON THE DISPLAY. THIS IS IN ERROR. THE CUSTOMER NOTED SEEING A BLANK SCREEN ON THE DISPLAY OF THE METER.

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. THE PRODUCT HAS BEEN REQUESTED BACK FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED GETTING A BOOKLET AND BATTERY ICON ON THE DISPLAY OF THEIR METER AND AS A RESULT OF BEING UNABLE TO TEST, THEY EXPERIENCED A HYPOGLYCEMIC EPISODE AS THE CUSTOMER WAS INCOHERENT AND DELIRIOUS. THE PARAMEDICS WERE CALLED AND TREATED CUSTOMER ON THE SCENE WITH ORAL AND IV GLUCOSE. THE CUSTOMER WAS NOT TRANSPORTED TO A HEALTH CARE FACILITY AND REPORTEDLY ALSO SELF-TREATED WITH FOOD TO COUNTERACT THE EVENT. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FLASH BLOOD GLUCOSE MONITORING SYSTEM NBW 0922328

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention