BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 1771743 · Received July 28, 2010

    Report

    Report Number
    2939301-2010-06005
    Event Type
    Injury
    Date Received
    July 28, 2010
    Date of Event
    July 13, 2010
    Report Date
    July 14, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE LAY USER/REPORTER CONTACTED LIFESCAN TO REPORT DIFFICULTY PROGRAMMING THE ONE TOUCH ULTRA 2 METER WITH THE CORRECT CALIBRATION CODE NUMBER. THE SR. MEDICAL SURVEILLANCE SPECIALIST WAS ABLE TO CLASSIFY THE COMPLAINT BASED ON THE INFORMATION ORIGINALLY PROVIDED. ON (B)(6) 2010, THE PATIENT WAS UNABLE TO PROGRAM THE REPORTED METER WITH THE CORRECT CALIBRATION CODE NUMBER FOR THE LOT OF TEST STRIPS IN USE. AFTERWARDS, THE PATIENT EXPERIENCED THE SYMPTOMS OF LIGHTHEADEDNESS, FATIGUE, SWEATING AND DIZZINESS. THE PATIENT CONSUMED FOOD AND/OR DRINK; HE DID NOT SEEK ANY MEDICAL ATTENTION OR TREATMENT. THE ISSUE WAS RESOLVED WITH PATIENT EDUCATION. THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS SUGGESTING SEVERE HYPOGLYCEMIA AFTER HE WAS UNABLE TO TEST HIS BLOOD GLUCOSE LEVEL DUE TO THE METER ISSUE, AND RECEIVED TREATMENT WITH FOOD. THEREFORE THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. 3027969

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Life Threatening| R