BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1243818 · Received November 24, 2008

    Report

    Report Number
    2939301-2008-03216
    Event Type
    Injury
    Date Received
    November 24, 2008
    Date of Event
    November 11, 2008
    Report Date
    November 12, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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 FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IN 2008, THE LAY USER/PATIENT CONTACTED LIFESCAN (SFS) ALLEGING THAT HER ONETOUCH ULTRA METER WAS NOT POWERING ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION, SINCE THE MEDICAL AFFAIRS SPECIALIST (MAS) WAS UNABLE TO REACH THE PATIENT BY PHONE. THE PATIENT REPORTED THAT THE ALLEGED ISSUE BEGAN AT 8PM ON A DAY PRIOR. APPROXIMATELY 45 MINUTES AFTER THE REPORTED ISSUE BEGAN, THE PATIENT CLAIMED SHE DEVELOPED SYMPTOMS OF SHAKINESS AND SWEATY PALMS AND IMMEDIATELY TREATED HERSELF WITH FOOD AND/OR A DRINK. THE PATIENT INFORMED THE CCA THAT SHE CURRENTLY MANAGES HER DIABETES WITH INSULIN (SELF ADJUSTER); HOWEVER, IT IS UNCLEAR WHAT ACTION THE PATIENT TOOK REGARDING HER DIABETES MANAGEMENT, IF ANY, AT ANY TIME THE REPORTED ISSUE BEGAN. THE PATIENT DENIED TESTING ON ANY OTHER DEVICE AT THE TIME OF THE EVENT. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THE SUBJECT METER DID NOT POWER ON WHEN THE POWER BUTTON WAS PRESSED; HOWEVER, THE CCA DOCUMENTED THAT IT DID POWER ON WHEN A TEST STRIP WAS INSERTED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THE COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE DUE TO THE REPORTED ISSUE, AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE 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 2864264

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Life Threatening| R