BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA2 METER

    MDR report key: 1033875 · Received April 25, 2008

    Report

    Report Number
    2939301-2008-00624
    Event Type
    Injury
    Date Received
    April 25, 2008
    Date of Event
    April 9, 2008
    Report Date
    April 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 HAS REQUESTED THE RETURN OF THE SUBJECT METER, TEST STRIPS, AND CONTROL SOLUTION FOR EVALUATION, 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/PATIENT CONTACTED LIFESCAN ALLEGING THAT A ONE TOUCH ULTRA 2 METER WOULD NOT POWER ON. THE PATIENT TESTS HIS BLOOD GLUCOSE 4 OR MORE TIMES A DAY. HE MANAGES HIS DIABETES VIA SELF-ADJUSTED INSULIN (UNKNOWN TYPE). THE PATIENT INDICATED THAT THE ALLEGED METER ISSUE STARTED A DAY BEFORE AT 6:00 AM. AT THE SAME TIME THE ISSUE BEGAN, THE PATIENT REPORTEDLY RECEIVED ASSISTANCE IN AN EMERGENCY ROOM (ER). THE PATIENT'S BLOOD GLUCOSE WAS TESTED ON AN ER/HOSPITAL METER AND A RESULT OF "27 MG/DL" WAS OBTAINED. THE PATIENT WAS TREATED WITH SUGAR. IN ADDITION, THE PATIENT WAS ALSO GIVEN HUMOLOG INSULIN (100 UNITS), HUMULIN NPH INSULIN (100 UNITS), GLYBURIDE (50 MG), AND "GLARGINE (50 MG)". IT IS NOT CLEAR AS TO WHY THE PATIENT WAS GIVEN THE MEDICATIONS FOR DIABETES. ON AN UNSPECIFIED DATE/TIME AFTER THE ALLEGED METER ISSUE BEGAN, THE PATIENT DEVELOPED SYMPTOMS OF DIZZINESS, FEVERS, SWEATING, AND LIGHTHEADEDNESS. IT WOULD HAVE BEEN HELPFUL TO KNOW THE FOLLOWING INFORMATION: WHAT ACTIONS THE PATIENT TOOK BEFORE AND AFTER THE SYMPTOMS DEVELOPED, WHY THE PATIENT WAS GIVEN THE DIABETES MEDICATIONS IN THE ER, IF THE PATIENT WAS HOSPITALIZED, WHAT DATE/TIME SYMPTOMS DEVELOPED, AND WHAT OTHER HEALTH CONDITIONS THE PATIENT HAS. IN ADDITION, IT WOULD HAVE BEEN HELPFUL TO VERIFY WHEN THE ALLEGED METER ISSUE BEGAN AND WHEN HE RECEIVED ASSISTANCE IN THE ER. THE REPORTED METER ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THE METER, TEST STRIPS, AND CONTROL SOLUTION WERE REPLACED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT ALLEGED THAT HE DEVELOPED SYMPTOMS, SOME OF WHICH CAN ASSOCIATED WITH SEVERE HYPOGLYCEMIA, AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2761792

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| L| R