BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1142757 · Received August 27, 2008

    Report

    Report Number
    2939301-2008-01945
    Event Type
    Injury
    Date Received
    August 27, 2008
    Report Date
    August 23, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER AND STRIPS FOR EVAL, BUT HAS NOT YET RECEIVED THEM. IF EITHER THE METER OR STRIPS ARE RETURNED, LIFESCAN WILL EVALUATE IT/THEM AND, IF EITHER THE METER OR STRIPS DO NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IN 2008, A PT CONTACTED LIFESCAN (LFS) ALLEGING THAT AN ONETOUCH ULTRA METER HAS A MISSING SEGMENT ISSUE. THE MEDICAL AFFAIRS SPECIALIST (MAS) WAS ABLE TO CONTACT THE PT TO OBTAIN ADDITIONAL INFO. THE PT TESTS HER BLOOD GLUCOSE THREE TIMES A DAY AND MANAGES HER DIABETES WITH PILLS, DIET AND EXERCISE. A DAY PRIOR, THE PT REPORTEDLY FIRST NOTICED THE SUBJECT METER'S DISPLAY HAD MISSING SEGMENTS. AS A RESULT OF THE ALLEGED METER ISSUE, THE PT CLAIMED THAT SHE CONTINUED WITH HER USUAL DOSE OF MEDICATIONS; HOWEVER, SHE STATED THAT SHE WAS AFRAID TO EAT SO SHE REDUCED HER MEAL INTAKE TO AVOID HIGH BLOOD SUGAR. THE PT CLAIMED THAT SHE "FELT ILL" AFTER THE REPORTED METER ISSUE. THE MAS CONTACTED THE PT AND WAS ABLE TO VERIFY THE PATIENT'S SPECIFIC SYMPTOMS RELATED TO "FEELING ILL." SHE STATED THAT ALONG WITH FEELING ILL, SHE FELT DIZZY, NAUSEATED AND SHAKY AFTER THE REPORTED METER ISSUE AND ON THE EVENT DATE IN THE EVENING TIME, THE PT CLAIMED THAT SHE HAD ADMINISTERED SELF-TREATMENT WITH FOOD AND REPORTEDLY "FELT BETTER." THE PATIENT'S PRODUCT HAS BEEN REPLACED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSIONS: THE PT CLAIMED THAT SHE DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Life Threatening| R