BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 2031880 · Received March 28, 2011

    Report

    Report Number
    2939301-2011-02647
    Event Type
    Injury
    Date Received
    March 28, 2011
    Report Date
    February 28, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510(K) # IS K062195.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRA METER WAS DISPLAYING AN ERROR 5 MESSAGE. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/PATIENT BY PHONE FOR FOLLOW-UP QUESTIONS. 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) 2011 (TIME NOT SPECIFIED). THE PATIENT DOES NOT TAKE ANY ORAL MEDICATION AND/OR INSULIN TO MANAGE HER DIABETES. ACCORDING TO THE CSR'S DOCUMENTATION, ON (B)(6) 2011, THE PATIENT EXERCISED (TIME UNSPECIFIED) IN RESPONSE TO THE REPORTED METER ISSUE. AS A RESULT OF THE ALLEGED ISSUE, THE PATIENT CLAIMED SHE EXPERIENCED SYMPTOMS OF SWEATING AND FELT NERVOUS AT AN UNSPECIFIED TIME LATER. THE PATIENT, HOWEVER, DENIED RECEIVING ANY MEDICAL INTERVENTION FOLLOWING THE ALLEGED PRODUCT ISSUE. IT IS NOT KNOWN HOW LONG THE PATIENT'S REPORTED SYMPTOMS CONTINUED ON FOR, IT IS NOT KNOWN IF THE PATIENT ASSOCIATED HER SYMPTOM WITH A HIGH OR LOW BLOOD GLUCOSE, AND IT IS NOT KNOWN IF THE PATIENT'S ALLEGED SYMPTOM OCCURRED AFTER EXERCISING. DURING TROUBLESHOOTING, THE CSR NOTED THE PATIENT DID NOT HAVE THE SUBJECT METER SET TO THE CORRECT CODE NUMBER (PER OWNER'S BOOKLET RECOMMENDATION). THE CSR GUIDED THE PATIENT THOUGH A RETEST AND THE ALLEGED ISSUE WAS RESOLVED. 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 HYPOGLYCEMIA 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. 3083962

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Life Threatening