BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONT TOUCH ULTRA2 METER

    MDR report key: 1658567 · Received April 9, 2010

    Report

    Report Number
    2939301-2010-02644
    Event Type
    Injury
    Date Received
    April 9, 2010
    Date of Event
    March 18, 2010
    Report Date
    March 29, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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

    ON (B) (6) 2010, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRA2 METER WAS READING INACCURATELY HIGH COMPARED TO ANOTHER DEVICE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION, SINCE THE MEDICAL SURVEILLANCE SPECIALIST WAS UNABLE TO REACH THE PATIENT BY PHONE. ON AN UNSPECIFIED DATE/TIME, THE PATIENT REPORTED OBTAINING BLOOD GLUCOSE READINGS OF "519 MG/DL" WITH THE SUBJECT METER AND "267 MG/DL" ON ANOTHER DEVICE (ONETOUCH BASIC), PERFORMED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <= 30%. THE CCA NOTED THAT THE PATIENT MANAGES HER DIABETES WITH INSULIN (SELF ADJUSTER). IT IS NOT KNOWN WHAT ACTION, IF ANY, THE PATIENT TOOK REGARDING HER DIABETES MANAGEMENT AS A RESULT OF THE ALLEGED INACCURATE RESULT. THE PATIENT DENIED DEVELOPING SYMPTOMS; HOWEVER, REPORTED THAT SHE WAS TREATED WITH IV GLUCOSE BY AN HCP ON (B) (6) 2010 AT APPROXIMATELY 3:15AM. THE PATIENT CLAIMED HER BLOOD GLUCOSE WAS "22 MG/DL" WHEN TESTED WITH A PARAMEDIC/EMT'S METER. IT WOULD HAVE BEEN HELPFUL TO KNOW WHEN THE PATIENT HAD LAST TESTED WITH THE SUBJECT METER AND WHAT RESULT WAS OBTAINED PRIOR TO THE ONSET OF SYMPTOMS. AT THE TIME OF TROUBLESHOOTING, THE CCA WALKED THE PATIENT THROUGH A CONTROL SOLUTION TEST AND NOTED THAT THE RESULT FELL OUTSIDE THE SPECIFIED CONTROL SOLUTION RANGE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY WAS TREATED FOR SEVERE HYPOGLYCEMIA BY AN HCP INJURY AFTER THE ALLEGED METER INACCURACY ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONT TOUCH ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2993923

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| L| R