BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1243953 · Received November 25, 2008

    Report

    Report Number
    2939301-2008-03256
    Event Type
    Injury
    Date Received
    November 25, 2008
    Report Date
    November 11, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED THE RETURN OF THE SUBJECT PRODUCT(S) FOR EVAL. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IN 2008, THE LAY USER/PT CONTACTED LIFESCAN ALLEGING THAT A ONE TOUCH ULTRA METER WOULD NOT POWER ON. THE PT INDICATED THAT THE ALLEGED METER ISSUE STARTED ON AN UNSPECIFIED DATE/TIME A MONTH PRIOR. THE PT DID NOT TAKE ANY ACTIONS RELATED TO DIABETES TREATMENT AS A RESULT OF THE ALLEGED METER ISSUE. THE PT DENIED DEVELOPING ANY SYMPTOMS DURING THE TIME OF CONCERN. HOWEVER, THE PT CLAIMED THAT ON THAT MONTH, SHE WAS HOSPITALIZED BECAUSE OF THE REPORTED METER ISSUE. THE PT MENTIONED THAT SHE WAS TREATED WITH IV FLUIDS. HER BLOOD GLUCOSE WAS TREATED ON AN ER/HOSPITAL METER BUT SHE WAS UNABLE TO RECALL WHAT RESULTS WERE OBTAINED. IT WOULD HAVE BEEN HELPFUL TO KNOW THE FOLLOWING INFO. THE PT'S TESTING FREQUENCY, HER MEDICATION AND DIABETES MANAGEMENT REGIMENS, WHY THE PT WAS HOSPITALIZED, AND WHAT ACTIONS THE PT TOOK BEFORE GOING TO THE HOSPITAL. THE REPORTED METER ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THE PT ADMITTED THAT SHE HAD NOT REPLACED THE METER'S BATTERY ACCORDING TO THE OWNER'S MANUAL. SHE DID NOT HAVE A REPLACEMENT BATTERY. THE METER AND TEST STRIPS WERE REPLACED. BASED ON THE INFO PROVIDED, THE COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION. THE PT CLAIMED THAT SHE IV FLUID TREATMENT AND WAS HOSPITALIZED AS A RESULT OF THE ALLEGED METER ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2685277

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Hospitalization| L| R