BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 1960438 · Received January 13, 2011

    Report

    Report Number
    2939301-2011-00472
    Event Type
    Injury
    Date Received
    January 13, 2011
    Report Date
    January 13, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    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 K053529.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING HER ONETOUCH ULTRA2 METER DISPLAYED AN "ER 2" MESSAGE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN IN (B)(6)2010. THE CCA WAS ADVISED THE PATIENT MANAGES HER DIABETES WITH GLUCOPHAGE PILLS (500 MG 2X A DAY) AND "LOMATAL" (20 MG ONCE A DAY). THE PATIENT STATED SHE CONTINUED TO TAKE HER USUAL DOSE OF MEDICATION; HOWEVER, IN (B)(6), STATED SHE WENT ON A STRONGER DOSAGE. ABOUT 2 MONTHS AFTER THE ALLEGED ISSUE BEGUN, THE PATIENT CLAIMED SHE FELT SYMPTOMS OF DIZZINESS AND HAD A "BLACKOUT." THE PATIENT DID NOT SPECIFY ANY TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE PATIENT WAS USING EXPIRED TEST STRIPS. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 2839116

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening