BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2120763 · Received June 10, 2011

    Report

    Report Number
    2939301-2011-04763
    Event Type
    Injury
    Date Received
    June 10, 2011
    Report Date
    May 27, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 K053529.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING AN UNUSUAL ISSUE WITH HER ONETOUCH ULTRA2 METER REVERTING BACK TO THE CALIBRATION CODE INSTEAD OF COUNTING DOWN AFTER BLOOD SAMPLE APPLICATION TO THE TEST STRIP. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN ABOUT 2 WEEKS AGO PRIOR TO CONTACTING LFS. THE CCA WAS ADVISED THE PATIENT MANAGES HER DIABETES WITH METFORMIN PILLS (2 PILLS DAILY) AND GLIPIZIDE PILLS (2 PILLS DAILY). THE PATIENT CONTINUED TO TAKE HER USUAL DOSE OF MEDICATIONS. ON THE FOLLOWING DAY AFTER THE ALLEGED ISSUE BEGUN, THE PATIENT CLAIMED SHE FELT SYMPTOMS OF BLURRED VISION, IRRITABLE AND LIGHT HEADED. THE PATIENT DENIED RECEIVING MEDICAL TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA TRIED TO WALK THE PATIENT THROUGH RESOLVING THE ALLEGED ISSUE. 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. 3003171

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Life Threatening