BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRASMART METER

    MDR report key: 2152275 · Received July 7, 2011

    Report

    Report Number
    2939301-2011-05563
    Event Type
    Injury
    Date Received
    July 7, 2011
    Report Date
    June 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

    THE METER INVOLVED WITH THIS COMPLAINT HAS/HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER HAS PASSED TESTING WITH NO FAULTS FOUND. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED. A 510(K) # IS K021819.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONETOUCH ULTRASMART METER WAS PROMPTING AN "ERROR 5" MESSAGE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION, SINCE THIS MEDICAL (B)(4) WAS UNABLE TO REACH THE PATIENT BY PHONE FOR ADDITIONAL INFORMATION. THE PATIENT REPORTED THAT THE ALLEGED ERROR MESSAGE BEGAN TO APPEAR ON AN UNSPECIFIED DAY IN (B)(6) 2011. THE PATIENT INFORMED THE CCA THAT HE MANAGES HIS DIABETES WITH ORAL MEDICATION(S). IT IS NOT KNOWN IF THE PATIENT MADE ANY CHANGES TO HIS USUAL DIABETES MANAGEMENT REGIMEN AS A RESULT OF THE ALLEGED METER ISSUE. APPROXIMATELY (B)(6) AFTER THE ALLEGED ISSUE STARTED, THE PATIENT CLAIMED HE DEVELOPED SYMPTOMS OF FEELING "SWEATY, DIZZY AND CONFUSED". THE PATIENT DENIED RECEIVED MEDICAL TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA WALKED THE PATIENT THROUGH A TEST AND NOTED THAT THE PATIENT WAS ABLE TO TEST SUCCESSFULLY. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS HE WAS UNABLE TO TEST HIS 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 ULTRASMART METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3130963

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening