BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA2 METER

    MDR report key: 1243822 · Received November 24, 2008

    Report

    Report Number
    2939301-2008-03221
    Event Type
    Injury
    Date Received
    November 24, 2008
    Report Date
    November 15, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM THE FDA OF PRODUCT(S) THAT DO NO PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IN 2008, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT A ONETOUCH ULTRA2 METER WAS REVERTING TO SETUP MODE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION SINCE MEDICAL AFFAIRS SPECIALIST (MAS) WAS UNABLE TO CONTACT THE PATIENT TO OBTAIN/VERIFY ADDITIONAL INFORMATION. THE PATIENT NORMALLY TESTS AT LEAST 4 TIMES DAILY AND MANAGES HER DIABETES WITH INSULIN (USUALLY REQUIRING NO DOSE ADJUSTMENTS). THE ALLEGED METER ISSUE STARTED ON APPROX TWO AND A HALF MONTHS EARLIER SOMETIME IN THE MORNING AND AS A RESULT, THE PATIENT CLAIMED THAT SHE CONTINUED WITH HER USUAL DOSE OF MEDICATION (100 UNITS OF LANTUS AND NOVOLIN 35 UNITS TID), WHICH IS ADJUSTABLE. ABOUT ONE WEEK AFTER THE METER ISSUE, THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS OF SWEATY AND SICK TO THE STOMACH BUT DID NOT RECEIVE ANY TREATMENT. IT IS UNKNOWN IF THE PATIENT WAS USING ANOTHER METER TO TEST HER BLOOD GLUCOSE WITH WHILE THE SUBJECT METER REPORTEDLY DID NOT WORK. THIS WAS NOT A NEW OUT OF BOX PRODUCT AND THERE WAS NO METER TRAUMA. THE ALLEGED ISSUE WAS RESOLVED WITH TROUBLESHOOTING. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AFTER THE REPORTED 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 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Life Threatening