BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI ENHANCED METER

    MDR report key: 2190229 · Received August 4, 2011

    Report

    Report Number
    2939301-2011-06826
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    July 8, 2011
    Report Date
    July 13, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 K061118.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRAMINI METER WAS DISPLAYING AN "ER2" MESSAGE. PER THE ONETOUCH ULTRAMINI OWNER'S BOOKLET, AN ERROR 2 MESSAGE CAN BE DUE TO "A STRIP OR METER PROBLEM". THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN ON (B)(6) 2011 AT 5:00PM. THE CCA WAS ADVISED BY THE PATIENT THAT SHE DOES NOT TAKE ANY MEDICATION TO MANAGE HER DIABETES AND DENIED MAKING ANY CHANGES TO HER NORMAL DIABETES MANAGEMENT ROUTINE IN RESPONSE TO THE REPORTED ISSUE. THE PATIENT CLAIMED TO HAVE DEVELOPED SYMPTOMS OF BEING "SHAKY" TEN MINUTES AFTER THE ALLEGED PRODUCT ISSUE OCCURRED AND TWENTY MINUTES LATER, SELF TREATED WITH FOOD/DRINK IN RESPONSE TO THE SYMPTOMS. AT THE TIME OF TROUBLESHOOTING, THE CCA DETERMINED THAT THE PATIENT WAS INSERTING THE TEST STRIP WITH THE BLOOD SAMPLE ALREADY APPLIED TO IT. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMED TO HAVE DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AND RECEIVED MEDICAL TREATMENT AFTER THE ALLEGED ISSUE OCCURRED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Life Threatening