BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 1923501 · Received December 13, 2010

    Report

    Report Number
    2939301-2010-10681
    Event Type
    Injury
    Date Received
    December 13, 2010
    Report Date
    November 29, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510(K) # IS K053529.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH ULTRA2 METER WOULD NOT POWER ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN 6 MONTHS AGO PRIOR TO CONTACTING LFS. THE CCA WAS ADVISED THE PATIENT MANAGES HIS DIABETES WITH A COMBINATION OF INSULIN AND PILLS (TYPES/ AMOUNTS NOT SPECIFIED). AT THE TIME OF THE ALLEGED ISSUE, THE PATIENT SKIPPED OR STOPPED HER USUAL DOSE OF MEDICATIONS. THE PATIENT DENIED DEVELOPING SYMPTOMS. DURING THAT SAME TIME, THE PATIENT STATED SHE VISITED HER PHYSICIAN'S OFFICE AND OBTAINED A BLOOD GLUCOSE RESULT OF "459 MG/DL" ON THE PHYSICIAN'S METER. THE PATIENT WAS ADMINISTERED INSULIN (TYPE/ AMOUNT NOT SPECIFIED). AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE PATIENT DROPPED THE SUBJECT METER IN WATER. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY RECEIVED MEDICAL INTERVENTION FROM A HEALTH CARE PROFESSIONAL (HCP) AFTER THE REPORTED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3037375

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R