BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 2233084 · Received September 2, 2011

    Report

    Report Number
    2939301-2011-08511
    Event Type
    Injury
    Date Received
    September 2, 2011
    Date of Event
    August 17, 2011
    Report Date
    August 17, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE ON HER ONETOUCH ULTRAMINI METER DUE TO IT REVERTING TO THE SET UP MODE. PER THE ONETOUCH ULTRAMINI OWNER'S BOOKLET, BEFORE TESTING ON THE METER, THE SETTINGS NEED TO BE CHECKED/RE-SET AFTER REMOVING AND REPLACING THE BATTERY. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE'S (CCA) DOCUMENTATION. THE PATIENT STATED THE ALLEGED ISSUE BEGAN ON (B)(6) 2011 AT APPROXIMATELY 10AM IN THE MORNING. THE PATIENT REPORTEDLY MANAGES HER DIABETES WITH A COMBINATION OF ORAL MEDICATION AND INSULIN. THE PATIENT ADMINISTERS HUMULIN 70/30 IN THE MORNINGS AND EVENINGS AND GLUCOVANCE 500MG PILLS TWICE, DAILY. THE PATIENT STATED THAT WHEN SHE WAS UNABLE TO CHECK HER BLOOD GLUCOSE, SHE CONTINUED WITH HER NORMAL DIABETES MANAGEMENT ROUTINE. APPROXIMATELY ONE HOUR AFTER THE ALLEGED ISSUE BEGAN, THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS OF "BLURRED VISION." THE REPORTER CLAIMED SHE TREATED HER SYMPTOM AT APPROXIMATELY 5PM THAT SAME DAY WITH AN EXTRA PILL OF GLUCOVANCE. THE PATIENT DENIED TESTING HER BLOOD GLUCOSE ON ANOTHER DEVICE. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THAT THE BATTERY HAD BEEN REMOVED/REPLACED JUST PRIOR TO THE ALLEGED ISSUE. THE CCA ASSISTED THE PATIENT WITH CHECKING THE METER SETTINGS AND RESOLVED THE ISSUE WITH TRAINING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND 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 ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3097089

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Life Threatening| R