BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2253491 · Received September 19, 2011

    Report

    Report Number
    2939301-2011-09166
    Event Type
    Injury
    Date Received
    September 19, 2011
    Date of Event
    September 9, 2011
    Report Date
    September 10, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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) HER ONETOUCH ULTRA2 METER WAS DISPLAYING TWO ERROR MESSAGES; ERROR 5 AND ANOTHER UNKNOWN ERROR MESSAGE USING TWO DIFFERENT LOTS OF TEST STRIPS. PER THE ONETOUCH ULTRA2 USER GUIDE, AN ERROR 2 MESSAGE COULD BE CAUSED EITHER BY A USED TEST STRIP OR A PROBLEM WITH THE METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE'S (CCA) DOCUMENTATION. THE PATIENT STATED THE ALLEGED ISSUES BEGAN ON (B)(6), 2011 AT APPROXIMATELY 2PM. THE PATIENT INFORMED THE CCA THAT SHE MANAGES HER DIABETES WITH ORAL MEDICATION (UNKNOWN TYPE/DOSE) ALONG WITH DIET AND EXERCISE. THE PATIENT DENIED TAKING ANY ACTION OR MAKING ANY CHANGES TO HER USUAL DIABETES MANAGEMENT ROUTINE WHEN THE ALLEGED ISSUES OCCURRED WITH THE SUBJECT METER. THE PATIENT CLAIMED THAT THE NEXT DAY AT AN UNSPECIFIED TIME, SHE DEVELOPED SYMPTOMS OF "DIZZINESS AND BLURRED VISION" BUT DENIED RECEIVING ANY FORM OF MEDICAL INTERVENTION. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE BLOOD TEST WAS PERFORMED CORRECTLY, THE BLOOD SAMPLE COMPLETELY FILLED THE CONFIRMATION WINDOW AND THE SUBJECT TEST STRIPS WERE STORED CORRECTLY AND UNEXPIRED. THE CCA WAS UNABLE TO RESOLVE THE ERROR 5 MESSAGE WITH TROUBLESHOOTING. THE UNKNOWN MESSAGE WAS UNRESOLVED ALSO SINCE THE PATIENT COULD NOT RECALL THE EXACT MESSAGE AND THE DEVICE READ "ERROR 5" AT THE TIME OF TROUBLESHOOTING. 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 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. 3193437

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening