BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 1916238 · Received December 7, 2010

    Report

    Report Number
    2939301-2010-10601
    Event Type
    Injury
    Date Received
    December 7, 2010
    Date of Event
    November 11, 2010
    Report Date
    November 11, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510 (K) # IS K053529. 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 ON (B)(6) 2010 ALLEGING THAT SHE WAS UNABLE TO USE HER ONE TOUCH ULTRA 2 METER SINCE SHE WAS HAVING DIFFICULTY SETTING IT UP. SHE MENTIONED THAT APPROXIMATELY 15-20 MINUTES AFTER TRYING TO USE THE METER ON (B)(6) 2010, SHE DEVELOPED SYMPTOMS OF "HIGH BLOOD SUGAR" AND WAS SWEATING. SHE DID NOT SEEK ANY MEDICAL ATTENTION OR CONTACT HER PHYSICIAN FOR ASSISTANCE. THE CUSTOMER CARE ADVOCATE (CCA) ASSISTED THE PATIENT AND THE ALLEGED ISSUE WAS RESOLVED OVER THE PHONE. PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT SINCE SHE WAS HAVING DIFFICULTY SETTING UP THE METER, SHE WAS UNABLE TO TEST AND DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3032277

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Life Threatening