BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 2170502 · Received July 21, 2011

    Report

    Report Number
    2939301-2011-06069
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    June 23, 2011
    Report Date
    June 24, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    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. 510(K) # IS K062195.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRA METER WAS DISPLAYING AN "ER5" MESSAGE. PER THE ONETOUCH ULTRA OWNER'S BOOKLET, AN ERROR 5 MESSAGE CAN BE DUE TO "INSUFFICIENT SAMPLE OR A METER/STRIP ISSUE". THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN AT AN UNSPECIFIED TIME ON (B)(6) 2011. THE CCA WAS ADVISED BY THE PATIENT THAT SHE TAKES 500MG OF METFORMIN TO MANAGE HER DIABETES BUT DENIED MAKING ANY CHANGES TO NORMAL DIABETES MANAGEMENT ROUTINE IN RESPONSE TO THE REPORTED ISSUE. WITHIN THIRTY MINUTES AFTER THE ALLEGED ISSUE BEGAN, THE PATIENT CLAIMED TO HAVE DEVELOPED SYMPTOMS OF BEING "DRUNK, DIZZY LIKE, DISORIENTED, AND SWEATY". THE PATIENT DENIED RECEIVING ANY MEDICAL TREATMENT DUE TO THESE SYMPTOMS. DURING THE TROUBLESHOOTING, THE CCA DETERMINED THAT THE METER WAS NOT CODED CORRECTLY BUT DID CONFIRM THAT THE PATIENT WAS USING THE CORRECT TYPE OF TEST STRIPS. THE CCA WENT THROUGH THE PROPER TESTING AND CODING PROCEDURES AS RECOMMENDED PER THE OWNER¿S BOOKLET. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE ALTHOUGH THE PATIENT DENIED ANY MEDICAL INTERVENTION, THE PATIENT CLAIMED TO HAVE DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED ISSUE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3139850

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Life Threatening