BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2810113 · Received October 31, 2012

    Report

    Report Number
    2939301-2012-12515
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    October 14, 2012
    Report Date
    October 15, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    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.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH ULTRA2 METER WAS REVERTING TO THE SET UP MODE WHEN SHE WAS TRYING TO TEST. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. ON (B)(6) 2012 AT 3PM, THE ALLEGED ISSUE FIRST STARTED. THE PATIENT REPORTED USING A COMBINATION OF MEDICATIONS INCLUDING NOVOLOG INSULIN ON A SLIDING SCALE AND LANTUS INSULIN 60 UNITS AT NIGHT. THE PATIENT REPORTED MAKING NO CHANGES TO HER USUAL DIET, ACTIVITY LEVEL OR MEDICATIONS DUE TO THE ALLEGED ISSUE. THE PATIENT REPORTED 1 HOUR LATER, SHE FELT "SWEATY." ON (B)(6) 2012 AT 4PM, THE PATIENT REPORTED HAVING SOMETHING TO EAT OR DRINK AS TREATMENT. THE PATIENT DENIED TESTING ON ANOTHER DEVICE. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THERE WAS NO MISUSE OF THE PRODUCT, AND THIS WAS NOT THE FIRST TIME THE METER HAS BEEN USED. THE PATIENT REPORTED THAT THE ALLEGED ISSUE DID OCCUR AFTER REPLACING THE BATTERY. REPLACEMENT PRODUCTS WERE SENT. THIS COMPLAINT IS BEING REPORTED AS AN ADVERSE EVENT SINCE THE PATIENT CLAIMS DUE TO THE ALLEGED ISSUE SHE DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AND REQUIRED SELF TREATMENT TO PREVENT FURTHER INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3295806

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Life Threatening| R