BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 1981747 · Received February 8, 2011

    Report

    Report Number
    2939301-2011-01201
    Event Type
    Injury
    Date Received
    February 8, 2011
    Report Date
    January 19, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (03/21/11)-DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE RETURNED METER HAS PASSED ALL TESTING WITH NO FAULTS FOUND. A DHR (DEVICE HISTORY RECORD) WAS COMPLETED FOR THE METER AND NO DEVIATIONS, NON-CONFORMANCES, OR REWORKS WERE OBSERVED. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    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 K062195.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONETOUCH ULTRA METER WAS REVERTING TO SETUP MODE. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE PATIENT ALLEGED THAT THE ISSUE BEGAN ON (B)(6) 2010 (TIME NOT KNOWN). IN ADDITION TO ORAL MEDICATION (TYPE AND DOSE UNSPECIFIED), THE PATIENT STATED HE ALSO MANAGES HIS DIABETES WITH DIET AND/OR EXERCISE. THE PATIENT, HOWEVER, DENIED TAKING ANY ACTION IN RESPONSE TO THE ALLEGED METER ISSUE. AS A RESULT OF THE REPORTED POWER ISSUE, THE PATIENT CLAIMED THAT ON EITHER (B)(6) 2011 HE DEVELOPED A SYMPTOM OF DRY MOUTH. THE PATIENT, HOWEVER, DENIED RECEIVING ANY MEDICAL INTERVENTION FOLLOWING THE ALLEGED METER ISSUE. DURING TROUBLESHOOTING, THE CSR DISCOVERED THE ALLEGED ISSUE OCCURRED AFTER THE PATIENT REMOVED/REPLACED THE SUBJECT METER'S BATTERY. THE CSR GUIDE THE PATIENT THROUGH THE SETUP MODE AND THE ALLEGED ISSUE WAS RESOLVED. 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 A SYMPTOM SUGGESTIVE OF HYPERGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3026333

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Life Threatening