BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 2032529 · Received March 29, 2011

    Report

    Report Number
    2939301-2011-02676
    Event Type
    Malfunction
    Date Received
    March 29, 2011
    Report Date
    March 10, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (05/10/2011)-DEVICE EVALUATION: THE LAY USER/PATIENT'S PRODUCT(S) INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6), 2011 WITH THE FOLLOWING FINDING: THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. PRODUCT ANALYSIS EVALUATED THE TEST STRIPS ON (B)(6), 2011 AND THE TEST STRIPS ALSO PASSED ALL 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.

    Description of Event or Problem · 1

    ON (B)(6) 2011, A REPORTER FOR THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH ULTRALINK METER READ INACCURATELY HIGH COMPARED TO ANOTHER DEVICE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN A WEEK AGO PRIOR TO CONTACTING LFS. THE REPORTER STATED THE PATIENT OBTAINED BLOOD GLUCOSE RESULTS OF "ABOUT 400 MG/DL" WITH THE SUBJECT METER AND "180 MG/DL" ON ANOTHER 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. THE CCA WAS ADVISED THE PATIENT MANAGES HER DIABETES WITH INSULIN (TYPE/ AMOUNT NOT SPECIFIED). THE PATIENT CONTINUED TO TAKE HER USUAL DOSE OF MEDICATION. ABOUT 15 MINUTES AFTER THE START OF THE ALLEGED ISSUE, THE REPORTER CLAIMED THE PATIENT HAD A HEADACHE. THE PATIENT WAS GIVEN FOOD AND/ OR DRINK AS TREATMENT. ON THE AFTERNOON OF (B)(6) 2011, THE PATIENT OBTAINED A BLOOD GLUCOSE RESULT OF "130 MG/DL" WITH ANOTHER DEVICE. 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. THE CCA EXPLAINED PROPER CLEANING OF THE PUNCTURE AREA PRIOR TO TESTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THERE IS NO INDICATION THAT THE REPORTED ISSUE CAUSED OR CONTRIBUTED TO A SERIOUS INJURY SINCE THE PATIENT SYMPTOM DID NOT CORRELATE WITH LFS'S DEFINITION SUGGESTIVE OF SEVERE HYPOGLYCEMIA OR HYPERGLYCEMIA. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE SUBJECT METER DID NOT MEET LFS' ACCURACY CRITERIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3067964

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR