BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2143374 · Received June 29, 2011

    Report

    Report Number
    2939301-2011-05343
    Event Type
    Injury
    Date Received
    June 29, 2011
    Report Date
    June 14, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ((B)(6) 2011)-THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: THE METER INVOLVED WITH THIS COMPLAINT FAILED TESTING. THE METER WAS FOUND TO HAVE DATA CORRUPTION. 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 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 1 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 SEVERAL MONTHS PRIOR TO CONTACTING LFS. IT IS NOT KNOWN IF THE PATIENT DISCONTINUED TESTING WITH THE SUBJECT METER AND IT IS NOT KNOWN IF THE PATIENT TESTED WITH ANOTHER DEVICE. THE PATIENT'S TESTING FREQUENCY IS NOT SPECIFIED; HOWEVER, THE PATIENT INDICATED SHE DOES NOT MANAGE HER DIABETES WITH ORAL MEDICATION OR INSULIN. FOLLOWING THE REPORTED METER ISSUE, THE PATIENT INDICATED SHE CONTINUED WITH HER USUAL DIABETES MANAGEMENT ROUTINE. ACCORDING TO THE CSR'S DOCUMENTATION, SEVERAL MONTHS PRIOR TO CONTACTING LFS, THE PATIENT REPORTEDLY DEVELOPED UNSPECIFIED SYMPTOMS OF HIGH BLOOD GLUCOSE (DATE/TIME NOT KNOWN); THE TIME DIFFERENCE BETWEEN THE START OF THE ALLEGED ISSUE AND THE ONSET OF THE PATIENT'S SYMPTOM(S) IS NOT KNOWN. THE PATIENT DENIED RECEIVING ANY MEDICAL INTERVENTION/TREATMENT AFTER THE REPORTED METER ISSUE BEGAN. DURING TROUBLESHOOTING, THE CSR NOTED THE PATIENT WAS NOT USING THE SUBJECT METER FOR THE FIRST TIME. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. 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 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. 3128420

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Life Threatening