BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRAMINI METER

    MDR report key: 1173432 · Received September 23, 2008

    Report

    Report Number
    2939301-2008-02357
    Event Type
    Injury
    Date Received
    September 23, 2008
    Date of Event
    September 9, 2008
    Report Date
    September 13, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    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 SHE WAS GETTING A MESSAGE ON HER ONE TOUCH ULTRAMINI METER. IT WAS NOT KNOWN AS TO WHAT THIS MESSAGE WAS. 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 HAD REPORTED THAT THE ALLEGED ISSUE FIRST OCCURRED IN THE MORNING OF TWELVE DAYS LATER. AS A RESULT OF THE ISSUE, SHE DID NOT TAKE ANY ACTIONS. SHE ALSO MENTIONED THAT AFTER THE REPORTED ISSUE BEGAN, SHE FELT "LOW AND SHAKY". SHE TREATED SELF WITH FOOD/BEVERAGE ON FOUR DAYS PRIOR TO ORIGINAL DATE AT 2:00 PM AND ALSO STATED THAT SHE WAS TESTED ON A FRIEND'S METER WITH A RESULT OF 52 MG/DL. AT THE TIME OF TROUBLESHOOTING, IT WAS VERIFIED THAT THIS WAS NOT A NEW PRODUCT. IT WAS DISCOVERED THAT THE PATIENT WAS SEEING THE MEMORY DUE TO PRESSING THE POWER BUTTON PRIOR TO INSERTING THE TEST STRIP TO TURN ON THE METER (USE ERROR). SHE WAS EDUCATED ON HOW TO POWER ON THE METER TO TEST AND THE ISSUE WAS RESOLVED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMED THAT SHE EXPERIENCED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AFTER THE REPORTED ISSUE BEGAN. SHE TREATED SELF WITH FOOD/BEVERAGE. THE ALLEGED ISSUE WAS RESOLVED WITH TROUBLESHOOTING. THE PATIENT DID NOT RECEIVE ANY MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2826678

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Life Threatening