BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1181627 · Received September 29, 2008

    Report

    Report Number
    2939301-2008-02448
    Event Type
    Injury
    Date Received
    September 29, 2008
    Date of Event
    September 23, 2008
    Report Date
    September 23, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER AND STRIPS FOR EVALUATION, BUT HAS NOT YET REC'D THEM. IF EITHER THE METER OR STRIPS ARE RETURNED, LIFESCAN WILL EVALUATE IT/THEM AND, IF EITHER THE METER OR STRIPS DO NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON THE EVENT DATE, AT 6:05 PM, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING A ONETOUCH ULTRA METER HAD A BATTERY INDICATOR ISSUE. THE MEDICAL AFFAIRS SPECIALIST (MAS) WAS ABLE TO CONTACT THE PT TO OBTAIN/VERIFY ADDITIONAL INFO. THE PT TESTS HER BLOOD GLUCOSE AT LEAST TWICE A DAY AND MANAGES HER DIABETES WITH PILLS, DIET AND EXERCISE. THE PT CURRENTLY TAKES METFORMIN 500 MG THREE TIMES A DAY. THE PT STATED THAT THE BATTERY INDICATOR ISSUE STARTED AT AROUND 7 AM ON THE SAME DAY. AS A RESULT OF THE METER ISSUE, THE PT DID NOT MAKE ANY CHANGES TO HER DIABETES REGIMEN OR DIET. SOMETIME AFTER THE METER STOPPED WORKING, THE PT STATED THAT SHE STARTED FEELING SHAKY AND STATED THAT SHE TESTED ON A FRIEND'S METER WITH REPORTED BLOOD GLUCOSE OF "100 MG/DL." AS A RESULT, THE PT ATE SOMETHING (NOT THE USUAL BREAKFAST) TO BRING HER BLOOD GLUCOSE CONCENTRATION BACK TO NORMAL (140-160 MG/DL)AND REPORTEDLY FELT BETTER AFTERWARDS. THE PT STATED THAT IF THE METER WORKED THEN SHE WOULD HAVE EATEN MORE TO MAINTAIN NORMAL BLOOD GLUCOSE. HOWEVER, DURING TROUBLESHOOTING, IT WAS DISCOVERED THAT THE PT FAILED TO CHANGE THE METER'S BATTERY PER THE OWNER'S MANUAL. THE PT'S PRODUCTS HAVE BEEN REPLACED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSIONS: THE PATIENT'S REPORTED SYMPTOM OF "SHAKY" CAN BE ASSOCIATED WITH HYPOGLYCEMIA AND IT REPORTEDLY DEVELOPED AFTER THE REPORTED METER ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2789844

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Life Threatening| R