BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 2132057 · Received June 16, 2011

    Report

    Report Number
    2939301-2011-04925
    Event Type
    Injury
    Date Received
    June 16, 2011
    Report Date
    June 11, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 K061118.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH ULTRAMINI METER WOULD NOT POWER ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN ON THE MORNING OF (B)(6) 2011. THE CCA WAS ADVISED THE PATIENT MANAGES HER DIABETES WITH METFORMIN PILLS (1000 MG), NOVOLIN R INSULIN (10 UNITS) AND LANTUS INSULIN (12 UNITS). THE PATIENT DENIED MAKING CHANGES TO HER DIABETES MANAGEMENT ROUTINE. ABOUT A WEEK AFTER THE ALLEGED ISSUE BEGUN, THE PATIENT CLAIMED SHE FELT SYMPTOMS OF BLURRY VISION AND FATIGUE. THE PATIENT DENIED RECEIVING MEDICAL TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THERE WAS NO MISUSE OF THE SUBJECT METER. THE CCA DISCOVERED THE SUBJECT METER TURNED ON WHEN THE POWER BUTTON WAS PRESSED BUT NOT WHEN A TEST STRIP WAS INSERTED. 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. 3025988

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Life Threatening