BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 3110461 · Received May 13, 2013

    Report

    Report Number
    3008382007-2013-11350
    Event Type
    Injury
    Date Received
    May 13, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 18, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K062195
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH ULTRA METER POWERS OFF DURING USE. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/PATIENT FOR FOLLOW-UP QUESTIONS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN ON (B)(6) 2013, AT 4AM. ABOUT 20 MINUTES PRIOR TO THE START OF THE ALLEGED ISSUE, THE PATIENT CLAIMED SHE FELT SYMPTOMS OF SHAKY AND SWEATY. THE PATIENT MANAGES HER DIABETES WITH METFORMIN PILLS AND LEVEMIR FLEX PEN INSULIN. IT IS NOT KNOWN IF THE PATIENT ASSOCIATED HER SYMPTOMS WITH HIGH OR LOW BLOOD GLUCOSE; HOWEVER, THE PATIENT REPORTEDLY INCREASED HER USUAL DOSE OF INSULIN (68 UNITS) AND METFORMIN PILLS (1 EXTRA PILL). THAT SAME DAY, EMERGENCY MEDICAL SERVICES (EMS) WAS REPORTEDLY CONTACTED AND TOOK THE PATIENT TO THE HOSPITAL. THE PATIENT WAS ADMINISTERED INTRAVENOUS (IV) GLUCOSE AS TREATMENT. RESULTS OBTAINED WITH THE EMS METER WERE NOT PROVIDED. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THERE WAS NO INDICATION OF MISUSE. THE CCA EDUCATED THE PATIENT ON METER BEHAVIOR AND THE AUTOMATIC SHUTOFF FEATURE TO RESOLVE THE ALLEGED ISSUE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND REPORTEDLY MAY HAVE INAPPROPRIATELY INCREASED HER USUAL DOSE OF MEDICATIONS RESULTING IN EMS INTERVENTION AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209799 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3446346

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Life Threatening| R