BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 2233541 · Received September 2, 2011

    Report

    Report Number
    2939301-2011-08517
    Event Type
    Injury
    Date Received
    September 2, 2011
    Report Date
    September 1, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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. THE 510K # K062195.

    Description of Event or Problem · 1

    THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ON (B)(6) 2011 ALLEGING THAT THE ONETOUCH ULTRA METER HAS AN ERROR 2 ISSUE. THIS COMPLAINT IS CLASSIFIED ACCORDING TO THE DOCUMENTATION OF THE CUSTOMER CARE ADVOCATE. THE PATIENT DOES NOT TAKE ANY MEDICATION TO MANAGE HIS DIABETES. REPORTEDLY, THE PATIENT WAS UNABLE TO USE THE SUBJECT METER TO TEST HER BLOOD GLUCOSE FOR 15 DAYS. AROUND (B)(6) 2011, THE PATIENT ALLEGEDLY DEVELOPED SYMPTOM OF "SWEAT" AND ADMINISTERED SELF TREATMENT WITH FOOD/DRINK. THE CUSTOMER CARE ADVOCATE WAS ABLE TO RESOLVE THE ERROR 2 ISSUE WITH TRAINING. IT WAS DISCOVERED THAT THE PATIENT WAS APPLYING THE SAMPLE INCORRECTLY AT THE TIME OF CONCERN. THIS COMPLAINT IS BEING REPORTED DUE TO USER ERROR AND BECAUSE THE PATIENT HAD SYMPTOM AND RECEIVED MEDICAL TREATMENT SUGGESTIVE FOR HYPOGLYCEMIA AFTER SHE WAS UNABLE TO USE THE SUBJECT METER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R