BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1192392 · Received October 6, 2008

    Report

    Report Number
    2939301-2008-02550
    Event Type
    Injury
    Date Received
    October 6, 2008
    Report Date
    September 26, 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 HAS REQUESTED THE RETURN OF THE SUBJECT METER, TEST STIRPS, AND CONTROL SOLUTION FOR EVAL, BUT HAS NOT YET RECEIVED THEM. IF EITHER THE METER, STRIPS, AND/OR CONTROL SOLUTION ARE RETURNED, LIFESCAN WILL EVALUATE THEM AND, IF EITHER THE METER, STRIPS, OR CONTROL SOLUTION 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/PT CONTACTED LIFESCAN ALLEGING THAT A ONE TOUCH ULTRA METER WAS REVERTING TO THE SETUP MODE. THE PT INDICATED THAT THE ALLEGED METER ISSUE STARTED ABOUT TWO DAYS PRIOR, AT 9:00 AM. HE CLAIMED THAT THE ISSUE STARTED AFTER HE HAD REMOVED/REPLACED THE METER'S BATTERY. AS A RESULT OF THE ALLEGED METER ISSUE, THE PT ADMINISTERED SELF-CARE BY TAKING HIS USUAL DOSAGES OF DIABETES MEDICATION. THE PT TOOK 30 UNITS OF NOVOLIN INSULIN IN THE MORNING AND 35 UNITS IN THE AFTERNOON. ON AN UNSPECIFIED DATE/TIME AFTER THE REPORTED ISSUE BEGAN. THE PT ALSO CLAIMED THAT HE DEVELOPED SYMPTOMS OF SHAKINESS AND SWEATING. THE PT DENIED RECEIVING MEDICAL INTERVENTION FROM A HEALTH CARE PROVIDER. DURING THE TIME OF CONCERN, THE PT WAS ABLE TO TEST HIS BLOOD GLUCOSE ON A BACKUP METER AND A RESULT OF "179 MG/DL" WAS REPORTED. IT IS NOT KNOWN WHAT DATE/TIME THE RESULT WAS OBTAINED AND IF THE PT WAS ABLE TO TEST HIS BLOOD GLUCOSE BEFORE AND AFTER THE SYMPTOMS STARTED. IT WOULD HAVE BEEN HELPFUL TO KNOW THE FOLLOWING INFO: THE PATIENT'S TESTING FREQUENCY, HIS MEDICATION AND DIABETES MANAGEMENT REGIMENS, WHEN THE REPORTED METER RESULT OF "179 MG/DL" WAS OBTAINED, WHAT DATE/TIME THE SYMPTOMS STARTED, AND WHAT ACTIONS THE PT TOOK BEFORE AND AFTER THE SYMPTOMS BEGAN. THE METER, TEST STRIPS, AND CONTROL SOLUTION WERE REPLACED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PT CLAIMED THAT THE DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN. IT IS NOT CLEAR AS TO THE DURATION OF TIME THE PT WAS UNABLE TO TEST HIS BLOOD GLUCOSE BEFORE THE SYMPTOMS STARTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2675963

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Life Threatening