BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1060352 · Received June 17, 2008

    Report

    Report Number
    2939301-2008-01056
    Event Type
    Injury
    Date Received
    June 17, 2008
    Report Date
    May 18, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 REC'D THEM. IF EITHER THE METER OR STRIPS ARE RETURNED. LIFESCAN WILL EVALUATED 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 ON 05/18/08 AND ALLEGED THAT SHE WAS HAVING A CALCODE ISSUE WITH HER ONE TOUCH ULTRA METER. THE MEDICAL AFFAIRS SPECIALIST WAS UNABLE TO REACH THE PT AFTER SEVERAL ATTEMPTS VIA PHONE. A LETTER WAS SENT TO THE ADDRESS PROVIDED. THE PT REPORTED THAT THE ALLEGED ISSUE FIRST OCCURRED ON THE DAY BEFORE APPROXIMATELY BETWEEN 2:00 - 3:00 PM. SHE ALSO MENTIONED THAT SHE WAS EXPERIENCING COLD SWEAT, HAD BUZZING IN HER EARS, AND FADING FEELING. AS A RESULT OF THE REPORTED ISSUE, SHE REPORTEDLY TOOK GLUCOSE. HOWEVER, SHE DID NOT RECEIVE/REQUIRE ANY MEDICAL ATTENTION AND WAS NOT TESTED ON ANY OTHER DEVICE. AT THE TIME OF TROUBLESHOOTING, THE PT WAS WALKED THROUGH RESOLVING THE ISSUE SUCCESSFULLY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PT CLAIMED TO HAVE EXPERIENCED SYMPTOMS SUGGESTING OF HYPOGLYCEMIA AFTER THE REPORTED ISSUE BEGAN. SHE TREATED SELF WITH GLUCOSE. THE ALLEGED ISSUE WAS RESOLVED WITH TROUBLESHOOTING. REPLACEMENT PRODUCT WERE SENT TO THE LAY USER/PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Life Threatening