BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRAMINI METER

    MDR report key: 1222082 · Received November 4, 2008

    Report

    Report Number
    2939301-2008-02921
    Event Type
    Injury
    Date Received
    November 4, 2008
    Date of Event
    October 14, 2008
    Report Date
    October 17, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 ULTRAMINI METER HAD AN UNSPECIFIED ERROR MESSAGE ISSUE. THE PATIENT INDICATED THAT THE ALLEGED METER ISSUE STARTED ON FOUR DAYS EARLIER, AT 7:00 AM. SHE WAS UNABLE TO RECALL WHAT SPECIFIC ERROR MESSAGE(S) APPEARED. THE PATIENT DID NOT TAKE ANY ACTIONS RELATED TO DIABETES TREATMENT AS A RESULT OF THE ALLEGED METER ISSUE. AT AN UNSPECIFIED TIME AFTER THE REPORTED ISSUE BEGAN, THE PATIENT CLAIMED THAT SHE DEVELOPED SYMPTOMS OF STAGGERING, FALLING, AND FEELING LIGHTHEADED. ON THE NEXT DAY, AT 2:00 PM, THE PATIENT ALLEGED THAT SHE RECEIVED ASSISTANCE FROM AN EMERGENCY ROOM (ER) BECAUSE OF THE METER ISSUE. THE PATIENT'S BLOOD GLUCOSE WAS TESTED ON AN ER/HOSPITAL METER AND A RESULT OF "320 MG/DL" WAS OBTAINED. THE PATIENT WAS REPORTEDLY TREATED WITH 40 UNITS OF LANTUS INSULIN. IT WOULD HAVE BEEN HELPFUL TO KNOW THE FOLLOWING INFORMATION: THE PATIENT'S TESTING FREQUENCY, HER MEDICATION AND DIABETES MANAGEMENT REGIMENS, IF THE PATIENT MADE ANY CHANGES TO THE REGIMENS OR HER DIET AS A RESULT OF THE METER ISSUE, AND WHAT ACTIONS THE PATIENT TOOK BEFORE AND AFTER THE SYMPTOMS DEVELOPED. THE PATIENT DID NOT HAVE THE REPORTED METER FOR TROUBLESHOOTING. THE METER, TEST STRIPS, AND CONTROL SOLUTION WERE REPLACED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED THAT SHE DEVELOPED SYMPTOMS AND RECEIVED INSULIN TREATMENT IN AN ER AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| L| R