BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 1962625 · Received January 18, 2011

    Report

    Report Number
    2939301-2011-00528
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Report Date
    December 27, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 HIS ONETOUCH ULTRALINK METER WAS READING INACCURATELY. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE LAY USER/PATIENT ON (B)(6) 2011 AND OBTAINED THE FOLLOWING INFORMATION: THE PATIENT TESTS FIVE TIMES A DAY AND MANAGES HIS DIABETES WITH AN INSULIN PUMP. THE PATIENT'S BLOOD GLUCOSE TYPICALLY IS BETWEEN "140-150MG/DL". WITH AN ELEVATED BLOOD GLUCOSE, THE PATIENT INDICATED HE WOULD EXPERIENCE A SYMPTOM OF FATIGUE AND WITH A LOW BLOOD GLUCOSE, THE PATIENT WOULD EXPERIENCE A SYMPTOM OF SWEATING. THE PATIENT CONFIRMED THAT THE ALLEGED ISSUE BEGAN ON (B)(6) 2010 (TIME UNKNOWN). THE PATIENT REPORTEDLY OBTAINED BLOOD GLUCOSE RESULTS OF "280 MG/DL" WITH THE SUBJECT METER AND "130 MG/DL" ON ANOTHER METER, PERFORMED WITHIN 2 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. IN RESPONSE TO THE RESULT WITH THE OTHER DEVICE, THE PATIENT STATED HE CONSUMED HIS BREAKFAST, DRANK HIS ORANGE JUICE, AND ADMINISTERED HIS INSULIN (AMOUNT UNKNOWN). THE PATIENT DENIED HE DEVELOPED ANY SYMPTOMS AND DENIED HE RECEIVED ANY TREATMENT AS A RESULT OF THE ALLEGED INACCURACY ISSUE. AT THE TIME OF TROUBLESHOOTING, THE CSR VERIFIED THE CORRECT UNIT OF MEASUREMENT ON THE SUBJECT METER AND NOTED THAT THE BLOOD GLUCOSE RESULTS WERE FROM THE APPROVED (PER OWNER'S MANUAL) SAMPLE SITE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THERE IS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT DID NOT SUFFER FROM ANY SERIOUS INJURIES AND DID NOT RECEIVE ANY FORM OF MEDICAL INTERVENTION. 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