BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRAMINI METER

    MDR report key: 1080448 · Received July 21, 2008

    Report

    Report Number
    2939301-2008-01454
    Event Type
    Injury
    Date Received
    July 21, 2008
    Report Date
    July 16, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 THE ERROR2 MESSAGE. THE MEDICAL AFFAIRS SPECIALIST (MAS) CALLED AND SPOKE WITH THE PATIENT ON JULY 18, 2008 AND OBTAINED ADDITIONAL INFORMATION. THE PATIENT REPORTED THAT THE ALLEGED ISSUE FIRST OCCURRED ON ORIGINAL DATE AT ABOUT 9:00 AM. SHE INFORMED THE MAS THAT SHE OBTAINED ERROR 2 MESSAGE ON THE METER THAT MORNING UNTIL THE AFTERNOON AT ABOUT 12:00 PM WHEN SHE ATTEMPTED TO TEST AGAIN. THE PATIENT IS NOT ON ANY DIABETES MEDICATIONS AND HAS BEEN DIAGNOSED WITH HYPOGLYCEMIA. AT AROUND 12:30 PM, SHE REPORTEDLY STARTED FEELING SHAKY. SHE CALLED HER DOCTOR AND WAS ADVISED TO TAKE A GLUCOSE TABLET. SHE FELT BETTER AFTER TAKING THAT. THE PATIENT WAS NOT TESTED ON ANY OTHER DEVICE. THE PATIENT TESTS HER BLOOD GLUCOSE 4-5 TIMES/DAY. AT THE TIME OF TROUBLESHOOTING, IT WAS VERIFIED THAT THIS WAS A NEW PRODUCT (SHE HAD JUST RECEIVED THE METER A DAY PRIOR TO THE EVENT). IT WAS DISCOVERED THAT THE PATIENT'S TESTING TECHNIQUE WAS INCORRECT (USE ERROR). THE CONDITION OF THE TEST STRIP WAS GOOD. THE ALLEGED ISSUE WAS RESOLVED WHEN A RETEST WAS PERFORMED WITH CORRECT TECHNIQUE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMED TO HAVE EXPERIENCED A SYMPTOM SUGGESTIVE A SEVERE HYPOGLYCEMIA, WHICH SHE TREATED SELF WITH A GLUCOSE TABLET PER HER DOCTOR'S ADVISE. THE ALLEGED ISSUE WAS RESOLVED WITH TROUBLESHOOTING (USE ERROR WAS INVOLVED). 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 2835458

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Life Threatening