BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1060337 · Received June 13, 2008

    Report

    Report Number
    2939301-2008-01084
    Event Type
    Injury
    Date Received
    June 13, 2008
    Report Date
    June 2, 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 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

    IN 2008, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONE TOUCH ULTRA METER WAS NO LONGER POWERING ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CONVERSATION, THE PT HAD WITH THE CUSTOMER CARE ADVOCATE (CCA), SINCE THE MEDICAL AFFAIRS SPECIALIST (MAS) WAS UNABLE TO REACH THE PT BY PHONE. THE PT REPORTED THAT THE ALLEGED ISSUE BEGAN A COUPLE OF WEEKS PRIOR TO CONTACTING LFS. DESPITE THE ALLEGED ISSUE, THE PT CLAIMED SHE CONTINUED TO ADMINISTER HER USUAL DOSE OF INSULIN (45 UNITS OF LANTUS). SOMETIME AFTER THE REPORTED ISSUE BEGAN, ON AN UNSPECIFIED DATE/TIME, THE PT "PASSED OUT" AND HAD TO RECEIVE ASSISTANCE FROM EMERGENCY MEDICAL SERVICES (EMS). THE PT DID NOT KNOW IF HER BLOOD GLUCOSE WAS CHECKED BY THE PARAMEDICS AT THE TIME OF THEIR ARRIVAL, BUT DID CONFIRM SHE WAS TREATED WITH IV GLUCOSE. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THERE WAS NO MISUSE TO THE SUBJECT METER AND THAT THE PT HAD NOT REPLACED THE BATTERY IN THE METER AS SUGGESTED IN THE OWNER'S BOOKLET. SINCE THE PT DID NOT HAVE A NEW BATTERY AT THE TIME OF TROUBLESHOOTING, THE ISSUE REMAINED UNRESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PT CLAIMS SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND REPORTEDLY HAD TO BE TREATED FOR HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2578220

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Life Threatening| R