BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 2052192 · Received April 12, 2011

    Report

    Report Number
    2939301-2011-03052
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Report Date
    March 25, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 ((B)(6) 2011) - DEVICE EVALUATION: THE TEST STRIPS INVOLVED WITH THIS COMPLAINT HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE TEST STRIPS HAVE 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, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRALINK METER WAS READING INACCURATELY ERRATIC. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE BEGAN ON THE EVENING OF (B)(6) 2011. THE PATIENT REPORTED BLOOD GLUCOSE READINGS OF "215 AND 146 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. AS PART OF THE PATIENT'S DIABETES MANAGEMENT ROUTINE, THE PATIENT INDICATED SHE IS ON AN INSULIN PUMP. DESPITE THE ALLEGED ISSUE, THE PATIENT DENIED TAKING ANY ACTION REGARDING HER DIABETES REGIMEN. AROUND THE SAME TIME THE ALLEGED ISSUE BEGAN, THE PATIENT CLAIMED SHE WAS FEELING SICK AND DIZZY. AT 11:30PM THAT EVENING THE PATIENT INDICATED SHE ADMINISTERED AN UNKNOWN DOSE OF BOLUS INSULIN. THE PATIENT ALSO STATED SHE TESTED ON ANOTHER BLOOD GLUCOSE DEVICE (BRAND UNKNOWN) AND OBTAINED A READING OF "217MG/DL". 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 DID NOT HAVE THE CONTROL SOLUTION AVAILABLE TO PERFORM A QUALITY CONTROL TEST. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THERE IS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THE PATIENT'S SYMPTOMS DO NOT MEET THE CRITERIA FOR A SERIOUS INJURY. THE ALLEGED READINGS CORRELATED WITH THE PATIENT'S TREATMENT. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED ISSUE REMAINED UNRESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3092400

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR