BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2983674 · Received February 28, 2013

    Report

    Report Number
    3008382007-2013-03951
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    November 14, 2013
    Report Date
    February 15, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE METER WAS FOUND TO HAVE STICKY BUTTON (519) AND LOW/DEAD BATTERY (420). IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2013 THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRA2 METER WOULD NOT POWER ON. THIS COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED POWER ISSUE STARTED ON (B)(6) 2012 AT 9:30PM. IT WAS DOCUMENTED THAT THE PATIENT MANAGES HER DIABETES WITH INSULIN (NO ADJUSTMENTS). THE PATIENT DENIED TAKING ANY ACTION REGARDING HER USUAL DIABETES MANAGEMENT REGIMEN DUE TO THE ALLEGED POWER ISSUE. HOWEVER, CLAIMED THAT 1 HOUR LATER SHE FELT NAUSEOUS AND FAINTED. AT 10:30PM THAT EVENING, THE PATIENT STATED SHE WAS TREATED WITH IV GLUCOSE BY EMS AFTER HER BLOOD GLUCOSE HAD TESTED AT "13" WITH THE EMS METER. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE SUBJECT METER'S BATTERY DID NOT NEED TO BE REPLACED. THE CCA CONFIRMED THE PATIENT WAS USING THE CORRECT TEST STRIPS. THE ALLEGED METER ISSUE REMAINED UNRESOLVED AT THE TIME OF THE CALL. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT WAS REPORTEDLY TREATED FOR SEVERE HYPOGLYCEMIA BY AN HCP AFTER THE ALLEGED METER POWER ISSUE STARTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87756 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3004619

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Life Threatening| R