BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 1970543 · Received January 25, 2011

    Report

    Report Number
    2939301-2011-00862
    Event Type
    Injury
    Date Received
    January 25, 2011
    Report Date
    January 6, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP # 1/SUPPLEMENTAL REPORT TEXT 02/22/2011. THE LAY USER/PATIENT'S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED IN THIS CASE HAS PASSED ALL TESTING WITH NO FAULTS FOUND. THE RETAIN TEST STRIPS ALSO PASSED ALL TESTING. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A SECOND FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED.

    Additional Manufacturer Narrative · 1

    FOLLOW UP # 2/SUPPLEMENTAL REPORT TEXT 03/04/2011. THE LAY USER/PATIENT'S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE TEST STRIPS INVOLVED IN THIS CASE HAVE PASSED ALL TESTING WITH NO FAULTS FOUND. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A SECOND FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER 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 K073231.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONETOUCH ULTRALINK METER WAS READING INACCURATELY LOW COMPARED TO A CALIBRATED LAB. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/PATIENT FOR FOLLOW-UP QUESTIONS ON (B)(6) 2011. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE BEGAN IN (B)(6) 2010 AT 8:00AM. THE PATIENT REPORTED BLOOD GLUCOSE RESULTS OF "140 MG/DL" WITH THE SUBJECT METER AND "180 MG/DL" ON A LABORATORY DEVICE, PERFORMED WITHIN 10 MINUTES OF EACH OTHER. BETWEEN THE TESTS THERE WAS NO INTERVENTION THAT WOULD BE EXPECTED TO CHANGE THE BLOOD GLUCOSE. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS LIFESCAN'S CRITERIA FOR ACCURACY. THE PATIENT INFORMED THE CCA THAT HE MANAGES HIS DIABETES WITH INSULIN PUMP. IT IS UNCLEAR IN THE DOCUMENTATION IF THE PATIENT MADE ANY CHANGES TO HIS DIABETES MANAGEMENT AT THE TIME OF THE ALLEGED ISSUE. THE PATIENT DENIED DEVELOPING SYMPTOMS. ON THE ONSET OF THE ALLEGED ISSUE, THE PATIENT CLAIMED HE SAW HIS HEALTH CARE PROVIDER (HCP). ACCORDING TO THE PATIENT, HE WAS ADMINISTERED 1 UNIT OF NOVOLOG INSULIN. THE PATIENT CLAIMED NO OTHER BLOOD GLUCOSE DEVICE WAS USED AT THE TIME OF THE DOCTOR'S OFFICE VISIT. AT THE TIME OF TROUBLESHOOTING, THE CCA VERIFIED THE PATIENT'S PROCESS FOR TESTING WAS CORRECT, THE SUBJECT METER'S UNIT OF MEASURE WAS CORRECT, AND AN APPROVED SAMPLE SITE WAS USED TO OBTAIN THE RESULT FROM THE SUBJECT METER. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMED HE OBTAINED AN INACCURATE LOW READING ON THE SUBJECT METER AND REPORTEDLY RECEIVED HCP INTERVENTION AFTER THE ALLEGED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3047251

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention