BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2061650 · Received April 18, 2011

    Report

    Report Number
    2939301-2011-03162
    Event Type
    Injury
    Date Received
    April 18, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 5, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER INVOLVED WITH THIS COMPLAINT HAS 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 K053529.

    Description of Event or Problem · 1

    ON (B)(6) 2011 THE LAY USER/PATIENT'S HUSBAND CONTACTED LIFESCAN (LFS) ALLEGING THAT THE PATIENT'S ONETOUCH ULTRA2 METER WAS READING INACCURATELY ERRATIC. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT'S HUSBAND REPORTED THE ALLEGED ISSUE BEGAN ON (B)(6) 2011 AT 5:00PM. THE PATIENT'S HUSBAND REPORTED BLOOD GLUCOSE READINGS OF "238, 122, AND 96 MG/DL" WITH THE SUBJECT METER, PERFORMED WITHIN 20 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <= 20% AND/OR <= 20 MG/DL. THE HUSBAND CLAIMED THE PATIENT MANAGES HER DIABETES WITH NOVOLOG AND LANTUS INSULIN. DESPITE THE ALLEGED ISSUE, THE HUSBAND INDICATED THE PATIENT DID NOT TAKE ANY ACTION REGARDING HER DIABETES REGIMEN. THE HUSBAND REPORTED THE PATIENT WAS FEELING SHAKY AFTER THE ALLEGED ISSUE BEGAN. IN RESPONSE TO THE SYMPTOM, AT 6:00PM THAT DAY, THE HUSBAND INDICATED THE PATIENT SELF-TREATED WITH FOOD AND/OR DRINK. ACCORDING TO THE HUSBAND, THE PATIENT DID NOT TEST ON ANY OTHER BLOOD GLUCOSE DEVICE AT THE TIME THE ALLEGED ISSUE BEGAN. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE SUBJECT METER'S UNIT OF MEASURE WAS SET CORRECTLY, THE PATIENT'S PROCESS FOR TESTING WAS CORRECT, AND THE RESULTS OBTAINED WERE FROM THE SAME APPROVED SAMPLE SITE. THE PATIENT'S HUSBAND WAS ABLE TO PERFORM A QUALITY CONTROL SOLUTION TEST. THE CONTROL SOLUTION RESULT FELL WITHIN THE SPECIFIED RANGE ON THE VIAL OF TEST STRIPS. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT'S HUSBAND REPORTED THE PATIENT DEVELOPED A SYMPTOM 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. 3037655

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Life Threatening| R