BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRAMINI METER

    MDR report key: 1060355 · Received June 17, 2008

    Report

    Report Number
    2939301-2008-01069
    Event Type
    Injury
    Date Received
    June 17, 2008
    Date of Event
    May 25, 2008
    Report Date
    May 30, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT PRODUCT FOR EVAL, BUT HAS NOT YET RECEIVED IT. IF THE PRODUCT WILL BE RETURNED, LIFESCAN WILL EVALUATED IT AND, IF IT DOES NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE LAY USER/PT CALLED LIFESCAN (LFS) IN 2008 AND ALLEGED THAT HER ONE TOUCH ULTRAMINI METER WAS SHOWING THE BATTERY INDICATOR. THE MEDICAL AFFAIRS SPECIALIST SPOKE WITH THE PT ON JUNE 10, 2008 AND VERIFIED THE FOLLOWING INFO. THE PT INDICATED THAT THE REPORTED ISSUE STARTED ABOUT ONE AND A HALF WEEK BEFORE SHE CALLED LIFESCAN AND SHE WAS UNABLE TO TEST HER BLOOD SUGAR DURING THAT TIME. ON FIVE DAYS PRIOR TO ORIGINAL DATE AT AROUND NOONTIME, SHE WAS FEELING NAUSEA, SHAKING, SWEATING, UPSET STOMACH, AND MILD CONFUSION. SHE TESTED HER BLOOD SUGAR ON ANOTHER METER AT WORK AND REPORTEDLY RECEIVED A READING OF 61 MG/DL. SHE ATE SOMETHING AND FELT BETTER. SHE STATED THAT SHE HAD NOT TESTED HER BLOOD SUGAR THAT DAY IN THE MORNING BEFORE SHE DEVELOPED THE REPORTED SYMPTOMS DUE TO THE ALLEGED ISSUE. SHE DENIED RECEIVING ANY MEDICAL ATTENTION DUE TO THE REPORTED ISSUE. SHE WAS EATING AS USUAL THAT DAY. THE CUSTOMER SERVICE AGENT (CSA) VERIFIED THAT THE PT HAD REPLACED THE BATTERY IN THE METER AS PER THE OWNER'S MANUAL. REPLACEMENT PRODUCTS HAVE BEEN SENT TO THE PT. THIS COMPLAINT IS BEING REPORTED AS AN ADVERSE EVENT, AS THE PT CLAIMED THAT SHE WAS UNABLE TO TEST HER BLOOD SUGAR DUE TO THE REPORTED ISSUE AND LATER, DEVELOPED THE SYMPTOMS INDICATIVE OF SEVERE HYPOGLYCEMIA AND PROVIDED SELF-TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2797679

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Life Threatening| R