BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA2 METER

    MDR report key: 1416750 · Received July 16, 2009

    Report

    Report Number
    2939301-2009-04407
    Event Type
    Injury
    Date Received
    July 16, 2009
    Date of Event
    May 15, 2009
    Report Date
    June 30, 2009
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 JUNE 30, 2009, THE LAY USER/PATIENT CONTACTED LIFESCAN ALLEGING THE ONE TOUCH ULTRA 2 METER READ IMPRECISELY. THE MEDICAL SURVEILLANCE SPECIALIST WAS NOT ABLE TO CONTACT THE PATIENT TO OBTAIN/CLARIFY INFORMATION. THE PATIENT REPORTED READINGS OF 132, 227, AND 295 MG/DL, PERFORMED WITHIN 10 MINUTES OF EACH OTHER ON THE PREVIOUS MONTH. BASED ON STATISTICAL CRITERIA, THE DIFFERENCE BETWEEN THESE RESULTS FALLS OUTSIDE THE EXPECTED VALUE OF <=20%. ON THE SAME DAY, THE PATIENT WENT TO THE EMERGENCY ROOM. ON THEIR METER, THE READING WAS 399 MG/DL. THE STAFF AT THE EMERGENCY ROOM INFUSED THE PATIENT WITH IV FLUIDS. THE TYPES OF FLUIDS ARE UNKNOWN. THE PATIENT MENTIONS THAT HE SELF-ADJUSTS HIS INSULIN DOSES. THERE IS NO MENTION OF ANY SYMPTOMS DUE TO THIS ISSUE. NO TROUBLESHOOTING WAS PERFORMED ON THE ISSUE. DETAILS OF HOW THE PATIENT USED THE ALLEGED READINGS AND WHY HE WENT TO THE EMERGENCY ROOM ARE UNKNOWN. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGED THE READINGS WERE INACCURATE AND NEEDED TO RECEIVE TREATMENT FROM HEALTH CARE PROFESSIONALS.

    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 24 YR Required Intervention