BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRASMART METER

    MDR report key: 1999671 · Received February 23, 2011

    Report

    Report Number
    2939301-2011-01593
    Event Type
    Injury
    Date Received
    February 23, 2011
    Date of Event
    December 24, 2010
    Report Date
    February 12, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510 (K) # IS K021819. 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

    THE LAY USER / PATIENT CONTACTED LFS ALLEGING MISSING SEGMENTS ON HER ONE TOUCH ULTRASMART METER. THE PATIENT MENTIONED THAT SHE FIRST NOTICED THE ALLEGED ISSUE WITH THE METER ON (B)(6) 2010 AT 11:20PM. DUE TO THE ALLEGED ISSUE, HE WAS UNABLE TO TEST AND ATE LESS FOOD/DRINK. SHE STARTED TO EXPERIENCE BLURRED VISION, SLEEPINESS AND FEELING DIZZY. SHE WENT TO THE ER AT 2:00AM AND WAS TREATED WITH 3 UNITS OF HUMALOG FOR A BLOOD GLUCOSE READING AROUND 213 MG/D-230MG/DL. THE PATIENT DENIED ANY MISUSE OF THE PRODUCT AND THIS WAS NOT THE FIRST TIME THE PRODUCT WAS BEING USED. METER WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE MISSING SEGMENTS, SHE WAS UNABLE TO TEST AND DEVELOPED SYMPTOM SUGGESTIVE OF A SERIOUS INJURY AND HAD TO RECEIVE MEDICAL TREATMENT IN THE ER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRASMART METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3030461

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Life Threatening| R