BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 3083702 · Received April 29, 2013

    Report

    Report Number
    3008382007-2013-09396
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    March 20, 2013
    Report Date
    April 16, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K061118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THE ONETOUCH ULTRAMINI METER WAS POWERING OFF DURING USE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE'S (CCA) DOCUMENTATION. THE PATIENT CLAIMED THE ALLEGED ISSUE BEGAN ON (B)(6) 2013, AT APPROXIMATELY 8PM. THE PATIENT MANAGES HIS DIABETES WITH AN UNKNOWN TYPE OF INSULIN AND IS A SELF ADJUSTER. SHE REPORTED INCREASING HER FOOD/DRINK INTAKE AS A RESULT OF THE ALLEGED ISSUE. SHE DENIED DEVELOPED ANY SYMPTOMS BUT FOR AN UNKNOWN REASON THE EMERGENCY MEDICAL SERVICES (EMS) WAS CONTACTED. IT IS NOT KNOWN WHAT THE PATIENT'S BLOOD GLUCOSE WAS WHEN THE EMS ARRIVED. THEY REPORTEDLY TREATED THE PATIENT WITH IV GLUCOSE AT APPROXIMATELY 8:10PM. HER BLOOD GLUCOSE WAS RETESTED AT APPROXIMATELY 8:30PM THAT NIGHT AND A READING OF "229 MG/DL" WAS OBSERVED. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE METER WAS NOT BEING USED FOR THE FIRST TIME. THE BATTERY NEEDED REPLACING BUT THE PATIENT DID NOT HAVE A NEW BATTERY AVAILABLE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT AND SUBJECT PRODUCTS ARE PENDING RETURN FOR INVESTIGATION. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY RECEIVED MEDICAL INTERVENTION FROM A HEALTH CARE PROFESSIONAL (HCP) AFTER THE REPORTED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183766 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3349543

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Life Threatening| R