BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 1969287 · Received January 24, 2011

    Report

    Report Number
    2939301-2011-00765
    Event Type
    Injury
    Date Received
    January 24, 2011
    Report Date
    January 15, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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; 510(K) # IS K062195.

    Description of Event or Problem · 1

    ON (B)(6), 2011, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HIS ONETOUCH ULTRA METER DISPLAYED AN 'ER 2' MESSAGE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN ON (B)(6), 2011 AT 2PM. THE CCA WAS ADVISED THE PATIENT MANAGES HIS DIABETES WITH METFORMIN PILLS (AMOUNT NOT SPECIFIED). THE PATIENT CONTINUED TO TAKE HIS USUAL DOSE OF MEDICATION. A COUPLE DAYS AFTER THE ALLEGED ISSUE BEGUN, THE PATIENT CLAIMED HE HAD 'CONSTANT URINATION.' THE PATIENT DENIED RECEIVING MEDICAL TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THERE WAS NO MISUSE OF THE SUBJECT METER. THE ALLEGED ISSUE OCCURS WHEN THE POWER BUTTON IS PRESSED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 2960676

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Life Threatening