BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 2070012 · Received April 26, 2011

    Report

    Report Number
    2939301-2011-03424
    Event Type
    Malfunction
    Date Received
    April 26, 2011
    Report Date
    April 11, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 (06/21/2011) - DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS/HAVE 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.

    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 HIGH COMPARED TO ANOTHER METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT WAS NOT ABLE TO SPECIFY WHEN THE ALLEGED ISSUE BEGAN. THE PATIENT REPORTED BLOOD GLUCOSE READINGS OF "204 MG/DL" WITH THE SUBJECT METER AND "136 MG/DL" ON ANOTHER METER(DOCTOR'S 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 CLAIMED SHE MANAGES HER DIABETES WITH AN INSULIN PUMP. DESPITE THE ALLEGED ISSUE, THE PATIENT INDICATED SHE CONTINUED TO ADMINISTER HER DOSE OF NOVOLOG INSULIN (DOSE NOT SPECIFIED) BASED ON HER BLOOD GLUCOSE READINGS. THE PATIENT DENIED DEVELOPING SYMPTOMS. IT IS NO KNOWN IF THE PATIENT RECEIVED ANY MEDICAL TREATMENT AFTER THE ALLEGED ISSUE BEGAN. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE SUBJECT METER'S UNIT OF MEASURE WAS SET CORRECTLY, THE PATIENT'S TESTING PROCEDURE WAS CORRECT, AND THE RESULTS OBTAINED WERE FROM AN APPROVED SAMPLE SITE. HOWEVER, A QUALITY CONTROL SOLUTION TEST WAS NOT PERFORMED SINCE THE PATIENT DID NOT HAVE THE CONTROL SOLUTION AVAILABLE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THERE IS NO INDICATION THAT THE REPORTED ISSUE CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT DID NOT DEVELOP SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA OR HYPERGLYCEMIA, NOR DID SHE RECEIVE MEDICAL INTERVENTION FOR EITHER OF THESE CONDITIONS. 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. 3104155

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR