BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCH ULTRAMINI METER

    MDR report key: 1060325 · Received June 13, 2008

    Report

    Report Number
    2939301-2008-01099
    Event Type
    Injury
    Date Received
    June 13, 2008
    Report Date
    June 11, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) IN 2008 ALLEGING INACCURATE HIGH READINGS ON HER ONE TOUCH ULTRA EASY METER. A MEDICAL AFFAIRS SPECIALIST (MAS) SENT QUESTIONS AND OBTAINED THE FOLLOWING INFORMATION: IN THE PREVIOUS MONTH, THE PATIENT STARTED TO USE HER ONETOUCH ULTRA EASY METER AND SINCE THEN SHE REPORTEDLY NOTICED HIGHER READINGS ON HER LFS METER COMPARED TO HER ACCUCHECK METER. DUE TO THE ALLEGED ELEVATED READING ON THE LFS METER, THE PATIENT CLAIMED SHE INCREASED HER INSULIN BASED ON HER PHYSICIAN'S RECOMMENDATIONS. SOMETIME DURING THAT MONTH, THE PATIENT TOOK HER BLOOD GLUCOSE READING ON THE LFS METER AND OBTAINED AN UNSPECIFIED RESULT. SHE THEN REPORTEDLY TOOK AN UNSPECIFIED AMOUNT OF INSULIN BASED ON THE LFS METER RESULT AND AT AN UNSPECIFIED TIME LATER, REPORTEDLY DEVELOPED HYPOGLYCEMIC SYMPTOMS (SHE FELT UNFOCUSED AND WAS SHIVERING). DUE TO HER SYMPTOMS, SHE ATE AND DRANK SOME APPLE JUICE. SHE FELT BETTER SOON AFTER SELF-TREATMENT. A WEEK LATER, THE PATIENT WAS ADMITTED IN THE HOSPITAL FOR 2.5 WEEKS DUE TO A WOUND ON HER LEG. WHILE IN THE HOSPITAL, SHE COMPARED HER ACCUCHECK METER WITH HER ULTRA EASY METER. THE ULTRA EASY METER READING WAS REPORTEDLY 100-200 POINTS HIGHER THAN THE ACCUCHECK METER (PATIENT DOES NOT RECALL READINGS ON EITHER DEVICES). A NORMAL READING FOR THE PATIENT IN THE MORNING IS BETWEEN 110-120 MG/DL AND BEFORE LUNCH BEFORE 140 MG/DL. THE TEST STRIPS WERE IN GOOD CONDITION AND NOT EXPIRED. THE TEST STRIP VIAL WAS NOT CRACKED OR BROKEN. THE TECHNIQUE OF APPLYING BLOOD ON THE TEST STRIP WAS CORRECT. THE PATIENT HAD CONTROL SOLUTION; HOWEVER, WAS UNABLE/UNWILLING TO RUN A QUALITY CONTROL TEST WITH THE CUSTOMER CARE ADVOCATE (CCA). CCA SENT THE PATIENT A REPLACEMENT METER. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT HAD ADJUSTED HER INSULIN BASED ON THE ALLEGED INACCURATE HIGH READINGS AND REPORTEDLY DEVELOPED HYPOGLYCEMIC SYMPTOMS AFTER THE REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCH ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2525039

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R