BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2003136 · Received February 28, 2011

    Report

    Report Number
    2939301-2011-01654
    Event Type
    Injury
    Date Received
    February 28, 2011
    Report Date
    February 16, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    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. 510(K) # IS K062195.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT IN (B)(6) CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONETOUCH ULTRA2 METER WAS DISPLAYING THE "APPLY SAMPLE" ICON DUE TO INCORRECT TEST STRIPS. THE CUSTOMER CARE REPRESENTATIVE (CCR) SPOKE TO THE PATIENT FOR ADDITIONAL FOLLOW UP QUESTIONS AND OBTAINED/VERIFIED THE FOLLOWING INFORMATION. THE PATIENT REPORTED THE ALLEGED ISSUE BEGAN AT AN UNKNOWN TIME IN (B)(6) 2010 PRIOR TO CONTACTING LFS. THE PATIENT CONFIRMED HE MANAGES HIS DIABETES WITH INSULIN. THE CSR NOTED THAT THE PATIENT DID NOT WISH TO PROVIDE ANY INFORMATION IF HE MADE ANY CHANGES TO HIS DIABETES MANAGEMENT DUE TO THE ALLEGED ISSUE. THE PATIENT INDICATED 3-8 MONTHS PRIOR TO THE START OF THE ALLEGED ISSUE, THE PATIENT MENTIONED HE WAS NOT HIMSELF AND HE ENDED UP IN A COMA FOR REASONS NOT KNOWN. ON (B)(6) 2010 AT AN UNKNOWN TIME, THE PATIENT CONFIRMED HE WENT TO THE EMERGENCY ROOM (ER) DUE TO THE ALLEGED ISSUE ON THE SUBJECT METER. AT THE TIME OF THE ER, THE PATIENT CONFIRMED/VERIFIED HE WAS TESTED BY THE ER/HOSPITAL METER AND OBTAINED A RESULT OF "41 MMOL/L". THE CSR NOTED THAT THE PATIENT DID NOT WISH TO PROVIDE ANY ADDITIONAL INFORMATION WHETHER HE RECEIVED ANY MEDICAL TREATMENT AFTER THE ALLEGED ISSUE BEGAN. AT THE TIME OF TROUBLESHOOTING, THE CSR NOTED IT WAS THE FIRST TIME THE PATIENT HAD USED THE SUBJECT METER AND DETERMINED THE PATIENT WAS USING THE INCORRECT TEST STRIPS. 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 RECEIVED MEDICAL TREATMENT FROM A HEALTH CARE PROFESSIONAL (HCP) AFTER THE REPORTED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3038010

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention