BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRASMART METER

    MDR report key: 2042671 · Received April 6, 2011

    Report

    Report Number
    2939301-2011-02855
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    March 18, 2011
    Report Date
    March 18, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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. 510(K) # IS K021819.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HE WAS NOT ABLE TO CHANGE THE CODE ON HIS ONETOUCH ULTRASMART METER. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/PATIENT FOR FOLLOW-UP QUESTIONS. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM LIFESCAN CUSTOMER SERVICE. THE PATIENT REPORTED THE ALLEGED ISSUE BEGAN ON (B)(6) 2011 AT 5:30AM. AS PART OF THE PATIENT'S DIABETES REGIMEN, THE PATIENT CLAIMED HE IS ON INSULIN. THE PATIENT DENIED TAKING ANY ACTION REGARDING HIS DIABETES MANAGEMENT ROUTINE AT THE TIME THE ALLEGED ISSUE BEGAN. THE PATIENT CLAIMED 30 MINUTES AFTER THE ALLEGED ISSUE BEGAN, HE FAINTED. IN RESPONSE TO THE SYMPTOM, THE PATIENT INDICATED HE TREATED HIMSELF WITH FOOD AND/OR DRINK. THE PATIENT INDICATED NO OTHER BLOOD GLUCOSE DEVICE WAS USED AT THE TIME OF THE ALLEGED ISSUE. AT THE TIME OF TROUBLESHOOTING, THE CCA WALKED THE PATIENT IN CHANGING THE CODE. THE ALLEGED ISSUE WAS RESOLVED WITH TRAINING. PER THE CCA DOCUMENTATION, THE PATIENT FELT IT WAS AN INTERMITTENT ISSUE, SO HE DID NOT FEEL COMFORTABLE USING THE SUBJECT METER. 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 SEVERE HYPOGLYCEMIA 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. 3055430

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R