BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI ENHANCED METER

    MDR report key: 2180428 · Received July 27, 2011

    Report

    Report Number
    2939301-2011-06471
    Event Type
    Injury
    Date Received
    July 27, 2011
    Date of Event
    June 22, 2011
    Report Date
    June 26, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 REPORTER FOR THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT THE PATIENT'S ONETOUCH ULTRAMINI METER WAS HAVING AN ISSUE WITH "OTHER MESSAGE". THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. ON THE MORNING OF (B)(6) 2011, THE PATIENT'S METER DISPLAYED THE ALLEGED "UNKNOWN ERROR MESSAGE". THE CCA WAS ADVISED BY THE REPORTER THAT THE PATIENT MANAGES HER DIABETES WITH ORAL MEDICATION (UNKNOWN TYPE AND DOSAGE), DIET AND EXERCISE AND DENIED MAKING ANY CHANGES TO THE PATIENT'S NORMAL DIABETES MANAGEMENT ROUTINE IN RESPONSE TO THE ALLEGED ISSUE. THE REPORTER CLAIMED THAT THE PATIENT DEVELOPED SYMPTOMS OF BEING "LIGHTHEADED AND JITTERY" BUT DENIED ANY TREATMENT IN RESPONSE TO THESE SYMPTOMS. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE REPORTER WAS "UNABLE AND/OR UNWILLING" TO GO THROUGH THE PROPER TESTING TECHNIQUE AS RECOMMENDED PER THE OWNER'S BOOKLET TO RESOLVE THE ALLEGED ISSUE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. ALTHOUGH THE PATIENT DENIED RECEIVING ANY MEDICAL INTERVENTION, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRAMINI ENHANCED METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3140902

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Life Threatening