BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1243794 · Received November 24, 2008

    Report

    Report Number
    2939301-2008-03205
    Event Type
    Injury
    Date Received
    November 24, 2008
    Report Date
    November 10, 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 RETURN OF THE SUBJECT PROD(S) FOR EVAL. IF THE PROD(S) ARE RETURNED, LIFESCAN WILL EVALUATE IT/THEM AND INFORM FDA OF PROD(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IN 2008, THE LAY-USER/PT CONTACTED LIFESCAN (LFS) ALLEGING THAT A ONE TOUCH ULTRA METER WOULD NOT POWER ON. THE PT INDICATED THAT THE ALLEGED METER ISSUE STARTED A WEEK PRIOR, AT AN UNK TIME. IT IS NOT CLEAR AS TO WHAT ACTIONS RELATED TO DIABETES TREATMENT THE PT TOOK IN RESPONSE TO THE METER ISSUE. HOWEVER, IT IS NOTED THAT THE PT EXERCISED ON THE DAY LIFESCAN WAS CONTACTED, AT 4:30 PM. FOUR DAYS PRIOR, THE PT CLAIMED THAT SHE DEVELOPED SYMPTOMS OF BLURRY VISION, A HEADACHE, SHAKINESS AND FREQUENT URINATION. ON ORIGINAL DATE, AT 1:30 PM, THE PT MENTIONED THAT HER BLOOD GLUCOSE WAS TESTED ON A DR'S/CLINIC'S METER AND A RESULT OF "379 MG/DL" WAS OBTAINED. ACCORDING TO THE PT, SHE AS TREATED BY A VISITING HOME HEALTH NURSE WITH ORAL MEDICATIONS FOR DIABETES. SHE WAS GIVEN METFORMIN, GLYBURIDE AND ACTOS. IT WOULD HAVE BEEN HELPFUL TO KNOW THE FOLLOWING INFO: THE PT'S TESTING FREQUENCY, HER MEDICATION AND DIABETES MGMT REGIMENS, AND WHAT ACTIONS THE PT TOOK BEFORE AND AFTER THE SYMPTOMS DEVELOPED. IN ADDITION, IT WOULD HAVE BEEN HELPFUL TO KNOW IF THE PT ALLEGED THAT SHE DEVELOPED SYMPTOMS OF HIGH AND/OR LOW BLOOD GLUCOSE. WHILE SPEAKING TO THE ONE TOUCH CUSTOMER ADVOCATE (OTCA), THE PT WAS ABLE TO TURN THE METER ON WITHOUT ANY ISSUES. THE METER, TEST STRIPS, AND CONTROL SOLUTION WERE REPLACED. BASED ON THE INFO PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PT CLAIMED THAT SHE DEVELOPED SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA 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 2790410

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Life Threatening| R