BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 1900308 · Received November 16, 2010

    Report

    Report Number
    2939301-2010-09908
    Event Type
    Malfunction
    Date Received
    November 16, 2010
    Report Date
    November 1, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2010, 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 (B)(6) 2010 AT AN UNSPECIFIED TIME. THE PATIENT REPORTED BLOOD GLUCOSE RESULTS OF "205, 231, AND 297 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 INDICATED SHE MANAGES HER DIABETES WITH INSULIN PUMP. DUE TO THE ALLEGED ISSUE, THE PATIENT CLAIMED SHE DECREASED HER DOSE OF INSULIN (TYPE AND DOSE UNKNOWN). THE PATIENT CLAIMED SHE WAS FEELING SLEEPY AND NAUSEAS IMMEDIATELY FOLLOWING THE ALLEGED ISSUE. THE PATIENT HOWEVER DENIED RECEIVING ANY MEDICAL TREATMENT DUE TO THE ALLEGED SYMPTOMS. AT THE TIME OF TROUBLESHOOTING, THE CCA VERIFIED AN APPROVED SAMPLE SITE WAS USED AND THAT THE SUBJECT METER'S UNIT OF MEASURE WAS SET CORRECT AT THE TIME OF TESTING. 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 PATIENT DID NOT RECEIVE ANY MEDICAL TREATMENT FOR ACUTE COMPLICATIONS OF DIABETES. 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. 3043954

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR