BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRAMINI METER

    MDR report key: 1173426 · Received September 23, 2008

    Report

    Report Number
    2939301-2008-02363
    Event Type
    Injury
    Date Received
    September 23, 2008
    Date of Event
    September 14, 2008
    Report Date
    September 17, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER AND STRIPS FOR EVALUATION, 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

    THE LAY USER/PATIENT CONTACTED LIFESCAN IN 2008 AND ALLEGED THAT HER ONE TOUCH ULTRAMINI METER WAS DISPLAYING A MESSAGE. THE MEDICAL AFFAIRS SPECIALIST WAS UNABLE TO REACH THE PATIENT AFTER SEVERAL ATTEMPTS VIA PHONE. A LETTER WAS SENT TO THE ADDRESS PROVIDED. THE PATIENT REPORTED THAT THE ALLEGED ISSUE FIRST OCCURRED ABOUT 3 DAYS PRIOR AT 7:30 PM. SHE ALSO MENTIONED THAT SHE SAW THE MEMORY AND WAS ATTEMPTED TO TEST IN THAT MODE. SHE REPORTEDLY TOOK NO DIABETES TREATMENT ACTIONS FOLLOWING THE ISSUE, BUT EXPERIENCED VOMITING, AND ALMOST PASSING OUT. SHE RECEIVED ASSISTANCE FROM THE EMERGENCY ROOM AND WAS TESTED ON THE ER METER WITH A RESULT OF "260 MG/DL" AND RECEIVED INSULIN TREATMENT. AT THE TIME OF TROUBLESHOOTING, IT WAS VERIFIED THAT THIS WAS NOT A NEW PRODUCT. THE PATIENT WAS WALKED THROUGH RESOLVING THE ISSUE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY EXPERIENCED SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA AFTER THE REPORTED ISSUE BEGAN AND THE ER METER RESULT REPORTEDLY CORRELATED WITH THE SYMPTOMS. SHE WAS TREATED WITH INSULIN. THE ALLEGED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. REPLACEMENT PRODUCTS WERE SENT TO THE LAY USER/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 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Life Threatening| R