BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRAMINI METER

    MDR report key: 1030030 · Received April 14, 2008

    Report

    Report Number
    2939301-2008-00567
    Event Type
    Injury
    Date Received
    April 14, 2008
    Date of Event
    April 1, 2008
    Report Date
    April 1, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT THE ONE TOUCH ULTRA MINI METER IS GIVING INACCURATE HIGH READINGS. THIS MEDICAL AFFAIRS SPECIALIST WAS UNABLE TO CONTACT THE PATIENT TO VERIFY INFORMATION GATHERED DURING THE INITIAL CALL OR OBTAIN FOLLOW UP INFORMATION. THE PATIENT INDICATED THAT THE REPORTED ISSUE FIRST OCCURRED ON THE SAME DAY AT 8:30 AM. THE PATIENT OBTAINED A BLOOD GLUCOSE READING OF "71 MG/DL" AND DECREASED HER LANTUS INSULIN TO 12 UNITS. AT AN UNSPECIFIED DATE AND TIME AFTER THE LANTUS INSULIN INTAKE, THE PATIENT DEVELOPED SYMPTOMS DESCRIBED AS "SHAKY." AT AN UNSPECIFIED TIME, MORE THAN 30 MINUTES AFTER THE "71 MG/DL" READING, THE PATIENT WAS TESTED ON AN EMT METER AT "51 MG/DL" AND WAS TREATED WITH FOOD/BEVERAGE. IT WOULD HAVE BEEN HELPFUL TO OBTAIN THE FOLLOWING INFORMATION: TESTING FREQUENCY, DIABETES MEDICATION REGIMEN, TIME OF LANTUS INSULIN INTAKE, TIME OF WHEN SYMPTOMS BEGAN, FOOD INTAKE, AND ANY CHANGES TO TESTING FREQUENCY AND DIABETES MEDICATION REGIMEN PRIOR TO OR AFTER THE REPORTED INCIDENT. DURING TROUBLESHOOTING, THE CUSTOMER CARE ADVOCATE VERIFIED THAT THE TESTING TECHNIQUE WAS CORRECT, THE PUNCTURE AREA WAS CLEANED APPROPRIATELY, AND REPORTED METER READINGS WAS CONFIRMED IN THE METER'S MEMORY. THE ACCURACY OF THE METER CANNOT BE DETERMINED, AS THE READINGS SHOULD BE TAKEN WITHIN 30 MINUTES AS PER LIFESCAN'S CRITERIA FOR ACCURACY COMPARISONS. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMED SHE DEVELOPED SYMPTOMS THAT CAN BE ASSOCIATED WITH SEVERE HYPOGLYCEMIA AND WAS TREATED FOR A LOW READING AFTER TAKING INSULIN BASED ON A LFS METER READING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2773357

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Life Threatening| R