BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 2853853 · Received December 3, 2012

    Report

    Report Number
    3008382007-2012-07021
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Report Date
    November 24, 2012
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K073231
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (02/04/2013)-DEVICE EVALUATION: THE PRODUCTS INVOLVED WITH THIS COMPLAINT HAVE BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS (PA) RESPECTIVELY ON (B)(4) 2013 AND (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE METER PASSED TESTING AND FUNCTIONED PROPERLY; NO FAULTS WERE FOUND. THE TEST STRIPS ALSO 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.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH ULTRALINK METER READ INACCURATELY HIGH. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN ON THE AFTERNOON OF (B)(6) 2012. THE PATIENT REPORTEDLY WENT TO THE HOSPITAL DUE TO FEELING HIGH BLOOD GLUCOSE SYMPTOMS AND TIRED. THE PATIENT REPORTED OBTAINING A BLOOD GLUCOSE RESULT OF "596 MG/DL" WITH THE SUBJECT METER AND "746 MG/DL" WITH A LABORATORY DEVICE. THE PATIENT MANAGES HER DIABETES WITH INSULIN THROUGH PUMP THERAPY. BASED ON THE ALLEGED RESULTS, THE PATIENT ADMINISTERED SELF 10 UNITS NOVOLOG INSULIN. A FEW HOURS AFTER THAT, THE PATIENT REPORTED BLOOD GLUCOSE RESULTS OF "441 MG/DL" WITH THE SUBJECT METER AND "216 MG/DL" ON THE HOSPITAL 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 PATIENT REPORTEDLY ADMINISTERED SELF AN ADDITIONAL DOSE OF NOVOLOG INSULIN (10 UNITS) BASED ON THE SUBJECT METER RESULT. NO ADDITIONAL TREATMENT WAS SPECIFIED. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT AND AN APPROVED SAMPLE SITE WAS USED FOR TESTING. THE CCA WAS NOT ABLE TO WALK THE PATIENT THROUGH QUALITY CONTROL TESTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THERE IS NO INDICATION THAT THE REPORTED ISSUE CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT'S SYMPTOMS AND TREATMENT CORRELATED WITH THE REPORTED LFS METER RESULTS. 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 EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1