BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 2011067 · Received March 8, 2011

    Report

    Report Number
    2939301-2011-01991
    Event Type
    Malfunction
    Date Received
    March 8, 2011
    Report Date
    February 25, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (03/18/2011)-DEVICE EVALUATION: 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.

    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 HER ONETOUCH ULTRALINK METER READ INACCURATELY ERRATIC WHEN COMPARING BLOOD GLUCOSE RESULTS TAKEN ONE AFTER ANOTHER. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE PATIENT ON (B)(6) 2011 AND OBTAINED THE FOLLOWING INFORMATION. THE MSS WAS ADVISED THE PATIENT TESTS HER BLOOD GLUCOSE 10X A DAY AND MANAGES HER DIABETES WITH NOVOLOG INSULIN. THE ALLEGED ISSUE BEGAN ON (B)(6) 2011 AT 730PM. THE PATIENT REPORTED BLOOD GLUCOSE RESULTS OF "300 AND 140 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 PATIENT DENIED MAKING CHANGES TO HER DIABETES MANAGEMENT ROUTINE. ABOUT 15 MINUTES AFTER THE START OF THE ALLEGED PRODUCT ISSUE, THE PATIENT CLAIMED SHE FELT HIGH BLOOD GLUCOSE SYMPTOM OF BLURRY VISION. THE PATIENT STATED SHE TREATED SELF WITH AN INCREASED DOSE OF INSULIN (AMOUNT NOT SPECIFIED). THE PATIENT STATED SHE OBTAINED A HIGH BLOOD GLUCOSE RESULT ON ANOTHER DEVICE; HOWEVER, DID NOT SPECIFY THE RESULT OBTAINED. AT THE TIME OF TROUBLESHOOTING, THE CUSTOMER CARE ADVOCATE (CCA) NOTED THE METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT AND AN APPROVED SAMPLE SITE WAS USED FOR TESTING. THE PATIENT DID NOT HAVE CONTROL SOLUTION TO TEST THE SUBJECT METER. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THERE IS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. GIVEN THE SHORT TIME BETWEEN THE ONSET OF THE ALLEGED ISSUE AND THE REPORTED SYMPTOMS, IT IS UNLIKELY THE PRODUCT ISSUE CONTRIBUTED TO THE REPORTED SYMPTOMS. IN ADDITION, THE PATIENT'S SYMPTOMS AND TREATMENT CORRELATED WITH THE REPORTED LFS METER RESULT. 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. 3082527

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR