BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 2082279 · Received May 9, 2011

    Report

    Report Number
    2939301-2011-03798
    Event Type
    Injury
    Date Received
    May 9, 2011
    Date of Event
    April 28, 2011
    Report Date
    April 28, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED. EVALUATION WAS UNABLE TO CONFIRM THE ALLEGED ISSUE-THE RETURNED METER PASSED TESTING WITH NO FAULTS FOUND. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    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 K061118.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH ULTRAMINI 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 10PM. THE CCA WAS ADVISED THE PATIENT MANAGES HER DIABETES WITH METFORMIN PILLS (1000 MG 2X DAILY) AND GLIPIZIDE PILLS (10 MG 2X DAILY). ON (B)(6) 2011 AT 730AM, THE PATIENT CLAIMED SHE FELT SYMPTOMS OF LIGHT HEADED AND BLURRY VISION. THE PATIENT DENIED RECEIVING MEDICAL TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THERE WAS NO MISUSE OF THE SUBJECT METER. 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 ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3056323

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Life Threatening