BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 2032845 · Received March 29, 2011

    Report

    Report Number
    2939301-2011-02679
    Event Type
    Injury
    Date Received
    March 29, 2011
    Report Date
    March 10, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS/HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER HAS PASSED TESTING WITH NO FAULTS FOUND. 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, A REPORTER FOR THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THE PATIENT'S ONETOUCH ULTRA METER DISPLAYED AN "ER 2" MESSAGE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN A YEAR AGO PRIOR TO CONTACTING LFS. THE CCA WAS ADVISED THE PATIENT MANAGES HIS DIABETES WITH NOVOLOG INSULIN (AMOUNT NOT SPECIFIED). THE PATIENT CONTINUED TO TAKE HIS USUAL DOSE OF MEDICATION. THE REPORTER CLAIMED THE PATIENT FELT A LOW BLOOD GLUCOSE SYMPTOM OF WEAK. ON THE MORNING OF (B)(6) 2011, THE REPORTER STATED THE PATIENT VISITED HIS PHYSICIAN'S OFFICE AND OBTAINED A BLOOD GLUCOSE RESULT OF "ABOUT 30 MG/DL" WITH THE PHYSICIAN'S METER. THE PATIENT WAS GIVEN FOOD AND/ OR DRINK AS TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THERE WAS NO MISUSE OF THE SUBJECT METER. THE PATIENT WAS USING EXPIRED TEST STRIPS FOR TESTING. THE CCA WAS UNABLE TO WALK THE PATIENT THROUGH RESOLVING THE ALLEGED ISSUE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY RECEIVED MEDICAL INTERVENTION FROM A HEALTH CARE PROFESSIONAL (HCP) AFTER THE REPORTED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 2840020

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Life Threatening| R