BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2241157 · Received September 9, 2011

    Report

    Report Number
    2939301-2011-08752
    Event Type
    Injury
    Date Received
    September 9, 2011
    Report Date
    August 21, 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'S GRANDSON CONTACTED LIFESCAN (LFS) ALLEGING THAT THE PATIENT'S ONETOUCH ULTRA2 METER WAS DISPLAYING AN UNKNOWN ERROR MESSAGE. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE REPORTER ALLEGED THAT THE ISSUE BEGAN IN THE AFTERNOON ON (B)(6) 2011 (TIME NOT SPECIFIED). THE PATIENT'S DIABETES MANAGEMENT IS NOT KNOWN AND IT IS UNCLEAR WHAT ACTION, IF ANY, THE PATIENT TOOK IN RESPONSE TO THE REPORTED METER ISSUE. AS A RESULT OF THE ALLEGED METER ISSUE, THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS OF THIRST AND TIREDNESS APPROXIMATELY TWO TO THREE DAYS LATER. THE REPORTER, HOWEVER, DENIED THE PATIENT RECEIVED ANY MEDICAL INTERVENTION/TREATMENT AFTER THE REPORTED ISSUE BEGAN. DURING TROUBLESHOOTING, THE CSR NOTED THERE WAS NO MISUSE OF THE LFS PRODUCT, THE PATIENT WAS NOT USING THE SUBJECT METER FOR THE FIRST TIME, AND THE ALLEGED ISSUE REMAINS UNRESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY 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 ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3142805

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Life Threatening