BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA2 METER

    MDR report key: 1222075 · Received November 4, 2008

    Report

    Report Number
    2939301-2008-02925
    Event Type
    Injury
    Date Received
    November 4, 2008
    Report Date
    October 19, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER AND STRIPS FOR EVALUATION, BUT HAS NOT YET RECEIVED 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

    IN 2008, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING A POWER ISSUE WITH THE ONETOUCH ULTRA2 METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE'S (CCA) DOCUMENTATION SINCE THE MEDICAL AFFAIRS SPECIALIST (MAS) WAS UNABLE TO CONTACT THE PATIENT TO OBTAIN ADDITIONAL INFORMATION. THE MAS MAILED A LETTER TO THE PATIENT ON OCTOBER 31, 2008. THE PATIENT TESTS HER BLOOD SUGAR 4 TIMES A DAY AND SHE MANAGES HER DIABETES VIA INSULIN ON SLIDING SCALE. THE PATIENT INDICATED THAT THE REPORTED ISSUE BEGAN ON FIVE DAYS PRIOR TO ORIGINAL DATE (TIME UNKNOWN), WHEN SHE REPORTEDLY PURCHASED THE SUBJECT METER. DURING THAT TIME, SHE REPORTEDLY NOTED THAT THE SUBJECT METER WOULD NOT TURN ON AND "WAS NOT SURE HOW TO USE THE METER." SHE THEN REPORTEDLY REMOVED THE BATTERIES FROM THE SUBJECT METER AND REINSERTED THEM UPSIDE DOWN. AS A RESULT OF THE REPORTED ISSUE WITH THE LFS PRODUCT, THE PATIENT REPORTEDLY HAD TO GUESS ON HER INSULIN AND REPORTEDLY TOOK ADDITIONAL 3 UNITS OF NOVOLOG INSULIN. AT AN UNSPECIFIED TIME, SHE REPORTEDLY OBTAINED A READING OF "332MG/DL" ON HER BACK UP (UNKNOWN) METER. IT IS NOT KNOWN WHETHER SHE INCREASED HER INSULIN BASED ON THE READING OF "332MG/DL" OBTAINED ON THE BACK UP METER. AFTER THE REPORTED ISSUE, AT AN UNSPECIFIED TIME, SHE REPORTEDLY EXPERIENCED "SWEATING". IT IS NOT KNOWN WHETHER SHE OBTAINED ANY BLOOD GLUCOSE READINGS DURING HER SYMPTOMS. THE PATIENT REPORTEDLY DID NOT RECEIVE/REQUIRE ANY MEDICAL ATTENTION. DURING THE TROUBLESHOOTING, WHEN THE CCA WALKED THE CUSTOMER THROUGH CORRECTLY INSTALLING THE BATTERIES, THE REPORTED ISSUE WAS RESOLVED. THE PATIENT'S PRODUCTS WERE REPLACED. BASED ON THE PROVIDED INFORMATION, THIS COMPLAINT IS BEING REPORTED SINCE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS THAT COULD BE SUGGESTIVE OF 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 2768043

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Life Threatening