BEUDAMED
    FDA Adverse Event Summary report: N

    OT ULTRAMINI METER

    MDR report key: 3093135 · Received May 3, 2013

    Report

    Report Number
    3008382007-2013-10191
    Date Received
    May 3, 2013
    Report Date
    April 9, 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
    AL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT THE ONETOUCH ULTRAMINI METER IS GIVING INACCURATE HIGH READINGS IN THE 200 RANGE. IN ADDITION, THE PATIENT MENTIONED THE SUBJECT METER READING IS READING 40 POINTS HIGHER THAN ANOTHER METER. THIS COMPLAINT IS CLASSIFIED ACCORDING TO THE DOCUMENTATION OF THE CUSTOMER CARE ADVOCATE. THE PATIENT'S DIABETES IS MANAGED WITH ORAL MEDICATION, DIET, AND EXERCISE. THE ALLEGED ELEVATED READINGS BEGAN (B)(6) 2012. THERE WAS NO ACTION TAKEN IN REGARDS TO HIS DIABETES MANAGEMENT BASED ON THE ALLEGED ISSUE. SUBSEQUENTLY, THE PATIENT DEVELOPED SYMPTOMS DESCRIBED AS "BROKE OUT IN SWEAT, WEAK, AND NAUSEATED" 3.5 MONTHS AFTER THE ONSET OF THE ISSUE. THE PATIENT WAS ABLE TO ADMINISTERED SELF TREATMENT WITH FOOD/DRINK ON (B)(6) 2013, AT 4:20 PM AND TESTED AT 118 MG/DL, ON ANOTHER METER AT 5:17 PM. DURING TROUBLESHOOTING, THE PATIENT CONFIRMED THE UNIT OF MEASUREMENT WAS CORRECTLY SET. THERE WAS NO CONTROL SOLUTION AT THE TIME TO PERFORM A QUALITY TEST. THE TEST STRIPS WERE WITHIN THE DISCARD DATE. THE LFS PRODUCTS WERE REPLACED AND REQUESTED BACK FOR INVESTIGATION. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT HAD SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AFTER THE INACCURACY ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194430 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Life Threatening