BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 1971723 · Received January 27, 2011

    Report

    Report Number
    2939301-2011-00890
    Event Type
    Malfunction
    Date Received
    January 27, 2011
    Report Date
    January 4, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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) 2011, THE LAY USER/PATIENT'S MOTHER CONTACTED LIFESCAN (LFS) ALLEGING THAT THE PATIENT WAS UNABLE TO TEST WITH HIS ONETOUCH ULTRALINK METER. THE CUSTOMER SERVICE REPRESENTATIVE (CSR) NOTED THE PATIENT WAS TESTING IN THE METER'S TESTING MODE. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CSR. THE PATIENT'S MOTHER ALLEGED THAT THE ISSUE BEGAN ON (B)(6) 2010 AT 2PM. THE PATIENT MANAGES HIS DIABETES WITH AN INSULIN PUMP. THE PATIENT'S MOTHER DENIED THE PATIENT TOOK ANY ACTION IN RESPONSE TO THE ALLEGED METER ISSUE. ACCORDING TO THE CSR'S DOCUMENTATION, A COUPLE HOURS AFTER THE REPORTED METER ISSUE OCCURRED, THE PATIENT DEVELOPED SYMPTOMS OF DEHYDRATION AND VOMITING. AT AN UNKNOWN TIME LATER, THE PATIENT'S MOTHER INDICATED THE PATIENT TESTED HIS BLOOD GLUCOSE WITH ANOTHER DEVICE (RESULT NOT SPECIFIED) AND THE PATIENT'S MOTHER ADMINISTERED AN UNSPECIFIED AMOUNT OF NOVOLOG INSULIN. AT THE TIME OF TROUBLESHOOTING, THE CSR REVIEWED THE PROPER TESTING TECHNIQUE WITH THE PATIENT'S MOTHER; HOWEVER, THE ALLEGED ISSUE REMAINED UNRESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. GIVEN THE SHORT TIME BETWEEN THE ONSET OF THE ALLEGED ISSUE AND THE REPORTED SYMPTOMS, THE PATIENT LIKELY FELT SYMPTOMATIC PRIOR TO OR WHEN THE ISSUE BEGAN. THEREFORE THE METER DID NOT CONTRIBUTE TO THE PATIENT'S SYMPTOMS. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED ISSUE REMAINS UNRESOLVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR