BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA2 METER

    MDR report key: 1343010 · Received March 11, 2009

    Report

    Report Number
    2939301-2009-01794
    Event Type
    Injury
    Date Received
    March 11, 2009
    Date of Event
    January 23, 2009
    Report Date
    February 24, 2009
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVAL. 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 2009, THE LAY PT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONE TOUCH ULTRA 2 METER READ INACCURATELY ERRATIC. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) CLASSIFIED THE COMPLAINT BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION SINCE THE MSS WAS UNABLE TO CONTACT THE PT BY PHONE. THE PT CLAIMED THAT SHE RECEIVED READINGS OF 241, 140, AND 109 MG/DL ON THE REPORTED PRODUCTS MORE THAN 20 MINUTES APART FROM EACH IN 2009. A VALID COMPARISON IN TERMS OF PRECISION CANNOT BE CALCULATED SINCE THE READINGS WERE OBTAINED > 20 MINUTES APART FROM EACH OTHER. ADDITIONALLY, THE CCA NOTED THAT THE PT CLEANED THE PUNCTURE SITE INCORRECTLY, WHICH CAN CONTRIBUTE TO INACCURATE READINGS. THE PT DENIED TAKING ACTION RELATED TO HER DIABETES AS A RESULT OF THE PRODUCT ISSUE. THE PT WAS UNSURE HOW MUCH TIME PASSED BETWEEN THE PRODUCT ISSUE AND WHEN SHE FELT SHAKY AND BLURRINESS; HOWEVER, THE CCA NOTED THE PT EXPERIENCED THESE SYMPTOMS AFTER THE PRODUCT ISSUE. THE PT DENIED RECEIVING TREATMENT. THE PT'S PRODUCTS WERE REPLACED. THE COMPLAINT IS REPORTED BECAUSE PT ALLEGES SHE OBTAINED INACCURATELY ERRATIC READINGS ON THE LFS PRODUCT AND AFTERWARD EXPERIENCED SYMPTOMS, WHICH CAN BE ASSOCIATED WITH HYPO OR HYPERGLYCEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2871941

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Life Threatening