BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1060353 · Received June 17, 2008

    Report

    Report Number
    2939301-2008-01055
    Event Type
    Injury
    Date Received
    June 17, 2008
    Report Date
    May 25, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 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/REPORTER CONTACTED LIFESCAN ALLEGING THAT A ONE TOUCH ULTRA METER HAD A BATTERY INDICATOR ISSUE AND WAS ALSO NOT POWERING ON. IT IS NOT KNOWN WHEN THE ALLEGED METER ISSUES BEGAN. AS A RESULT OF THE REPORTED METER ISSUES, THE PT REPORTEDLY ADMINISTERED SELF-CARE BY TAKING AN INCREASED DOSE OF GLUCOPHAGE. THE PT TOOK ONE EXTRA 500 MG TABLET OF GLUCOPHAGE PER DAY. IT IS NOT CLEAR IF THE PT TOOK ONE OR MORE EXTRA DOSES OF GLUCOPHAGE DURING THE TIME OF CONCERN. ON AN UNSPECIFIED DATE/TIME AFTER THE ISSUE BEGAN, THE PT REPORTEDLY DEVELOPED SYMPTOMS OF SHAKINESS, HEADACHES, WEAKNESS, NAUSEA, AND FEELING SICK. ALSO, ON AN UNK DATE/TIME DURING THE TIME OF CONCERN, THE PT'S BLOOD GLUCOSE WAS TESTED ON AN UNIDENTIFIED DEVICE AND A RESULT OF "480 MG/DL." IT IS NOT KNOWN IF THE REPORTED RESULT WAS OBTAINED BEFORE, DURING, OR AFTER THE PT DEVELOPED THE SYMPTOMS. IT WOULD HAVE BEEN HELPFUL TO KNOW THE FOLLOWING INFO: HOW LONG THE ALLEGED METER ISSUES HAD BEEN OCCURRING BEFORE HE DEVELOPED THE SYMPTOMS, WHAT ACTIONS THE PT TOOK BEFORE AND AFTER THE SYMPTOMS DEVELOPED, HIS TESTING FREQUENCY, AND THE DETAILS OF HIS DIABETES MGMT REGIMEN. IN ADDITION, IT WOULD HAVE BEEN HELPFUL TO KNOW WHEN THE RESULT OF "480 MG/DL" WAS OBTAINED AND IF THE PT WAS ADVISED BY AN HCP TO INCREASE HIS GLUCOPHAGE DOSAGES. THE ALLEGED METER ISSUES WERE NOT RESOLVED WITH TROUBLESHOOTING. THE METER, TEST STRIPS, AND CONTROL SOLUTION WERE REPLACED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE REPORTER CLAIMED THAT THE PT DEVELOPED SYMPTOMS THAT CAN BE ASSOCIATED WITH SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUES 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 2655311

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Life Threatening