BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STATSTRIP GLUCOSE METER

    MDR report key: 4609238 · Received March 10, 2015

    Report

    Report Number
    MW5041459
    Event Type
    Injury
    Date Received
    March 10, 2015
    Date of Event
    February 27, 2015
    Report Date
    March 10, 2015
    Manufacturer
    NOVA BIOMEDICAL CORP.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER NOTICED BATTERY COVER ON NOVA BIOMEDICAL CORPORATION, STATSTRIP BLOOD GLUCOSE METER WAS NOT SEATED CORRECTLY. USER REMOVED BATTERY COVER AND DISCOVERED THE BATTERY PACK HAD CONSIDERABLE SWELLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163993 STATSTRIP GLUCOSE METER STATSTRIP GLUCOSE METER NBW NOVA BIOMEDICAL CORP. STATSTRIP

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention STATSTRIP/STATSENSOR/XPRESS BLOOD GLUCOSE METER