BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 1882036 · Received October 25, 2010

    Report

    Report Number
    2939301-2010-09423
    Event Type
    Injury
    Date Received
    October 25, 2010
    Report Date
    October 3, 2010
    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

    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.THE 510(K) # IS K053529.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRA2 METER DISPLAYS AN ERROR 2 MESSAGE. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE 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) 2010 AT 9:45AM. THE PATIENT INDICATED SHE MANAGES HER DIABETES WITH INSULIN (SELF ADJUSTER); HOWEVER, THE PATIENT DENIED TAKING ANY ACTION AFTER THE ALLEGED ISSUE BEGAN. ON AN UNSPECIFIED DATE/TIME, THE PATIENT CLAIMED SHE EXPERIENCED SYMPTOMS OF DIZZINESS, SWEATING, NAUSEA, AND LIGHTHEADEDNESS AS A RESULT OF THE ALLEGED ISSUE. THE PATIENT, HOWEVER, DENIED RECEIVING MEDICAL INTERVENTION OR TREATMENT FOLLOWING THE ALLEGED ISSUE. IT IS NOT KNOWN IF THE PATIENT TESTED WITH ANTHER DEVICE. AT THE TIME OF TROUBLESHOOTING, THE CSR VERIFIED THE PATIENT WAS USING THE CORRECT TEST STRIPS, THERE WAS NO MISUSE OF THE LFS PRODUCT, AND THE PATIENT WAS USING THE 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 SUGGESTIVE OF A SERIOUS INJURY 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. 2925375

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Life Threatening