BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 2061673 · Received April 18, 2011

    Report

    Report Number
    2939301-2011-03165
    Event Type
    Injury
    Date Received
    April 18, 2011
    Date of Event
    April 8, 2011
    Report Date
    April 10, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (06/07/2011)-DEVICE EVALUATION: THE LAY USER/PATIENT'S PRODUCT(S) INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: ON MAY 16, 2011 THE METER PASSED TESTING WITH NO FAULTS FOUND. ON (B)(6), 2011 THE TEST STRIPS PASSED ALL TESTING WITH NO FAULTS FOUND. THE RETAIN TEST STRIPS ALSO PASSED ALL TESTING. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    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, A REPORTER FOR THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THE PATIENT'S ONETOUCH ULTRA METER READ INACCURATE COMPARED TO ANOTHER DEVICE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN ON (B)(6) 2011 AT 7AM. THE REPORTER STATED THE PATIENT OBTAINED BLOOD GLUCOSE RESULTS OF "100 MG/DL" WITH THE SUBJECT METER AND "38 MG/DL" ON ANOTHER METER, PERFORMED GREATER THAN 30 MINUTES OF EACH OTHER. THE CCA WAS ADVISED THE PATIENT MANAGES HIS DIABETES WITH HUMALOG INSULIN (10 UNITS), LANTUS INSULIN (44 UNITS) AND "GLUCOXIDE" (5 MG). THE PATIENT CONTINUED TO TAKE HIS USUAL DOSE OF MEDICATIONS. PRIOR TO THE ALLEGED ISSUE, THE REPORTER CLAIMED THE PATIENT FELT SYMPTOMS OF WEAK, SWEATY AND WAS IN A "DRUNKEN STATE." BY 830AM THAT SAME MORNING, EMERGENCY MEDICAL SERVICES (EMS) ADMINISTERED THE PATIENT INTRAVENOUS (IV) GLUCOSE AS TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT AND AN APPROVED SAMPLE SITE WAS USED FOR TESTING. 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. 3094086

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Life Threatening| R