BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 2061585 · Received April 18, 2011

    Report

    Report Number
    2939301-2011-03148
    Event Type
    Injury
    Date Received
    April 18, 2011
    Date of Event
    April 3, 2011
    Report Date
    April 4, 2011
    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

    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 K073231.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT'S MOTHER CONTACTED LIFESCAN (LFS) ALLEGING THAT THE PATIENT'S ONETOUCH ULTRALINK METER WAS READING INACCURATELY HIGH. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/PATIENT'S MOTHER FOR FOLLOW-UP QUESTIONS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT'S MOTHER REPORTED THE ALLEGED ISSUE BEGAN ON (B)(6) 2011 AT 8:00PM. THE PATIENT'S MOTHER REPORTED BLOOD GLUCOSE READINGS OF "600 MG/DL" WITH THE SUBJECT METER AND "123 MG/DL" ON ANOTHER METER (ONETOUCH ULTRALINK METER), PERFORMED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <= 30% AND/OR <= 30 MG/DL. ACCORDING TO THE CCA DOCUMENTATION, THE MOTHER STATED THE PATIENT WAS NOT TAKING ANY DIABETES MEDICATIONS, BUT CONTINUED TO FOLLOW HIS DIABETES MANAGEMENT ROUTINE AT THE TIME THE ALLEGED ISSUE BEGAN. THE MOTHER STATED THE PATIENT WAS EXPERIENCING "LOW BLOOD SUGAR SYMPTOMS" 1 ½ HOURS AFTER THE ALLEGED ISSUE BEGAN. IN RESPONSE TO THE PATIENT'S SYMPTOMS, THE MOTHER REPORTED THE PATIENT ADMINISTERED GLUCOSE TABLETS/GLUCOSE GELS. AT THE TIME THE ALLEGED ISSUE BEGAN, THE MOTHER INDICATED NO OTHER BLOOD GLUCOSE DEVICE WAS USED BY THE PATIENT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE SUBJECT METER'S UNIT OF MEASURE WAS SET CORRECTLY, THE RESULTS OBTAINED WERE FROM THE SAME APPROVED SAMPLE SITE, AND THE PATIENT'S PROCESS FOR TESTING WAS CORRECT. THE PATIENT'S MOTHER DID NOT HAVE THE CONTROL SOLUTION TO PERFORM A QUALITY CONTROL TEST. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT'S MOM CLAIMS THE PATIENT OBTAINED AN INACCURATE HIGH READING ON THE SUBJECT METER AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 2977879

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Life Threatening| R