BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 1982938 · Received February 9, 2011

    Report

    Report Number
    2939301-2011-01256
    Event Type
    Malfunction
    Date Received
    February 9, 2011
    Report Date
    February 4, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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. 510K # K073231.

    Description of Event or Problem · 1

    THE MEDICAL SURVEILLANCE SPECIALIST (MSS) CLASSIFIED THIS COMPLAINT BASED ON CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) CUSTOMER SERVICE ON FEBRUARY 4, 2011 ALLEGING THAT THE ONETOUCH ULTRALINK METER IS GIVING INACCURATE HIGH READING OF "152 MG/DL" COMPARED TO THE ONETOUCH ULTRAMINI METER READING OF "84 MG/DL." NOTEABLELY, THE PATIENT HAD SYMPTOMS DESCRIBED AS "HALOS IN HER EYES" 30 MINUTES PRIOR TO THE ALLEGED INACCURATE HIGH ISSUE. ON (B)(6) 2011 AT 2 PM, THE PATIENT OBTAINED THE ALLEGED INACCURATE READING ON THE SUBJECT METER. THE PATIENT DID NOT REQUIRE ANY MEDICAL INTERVENTION THAT WOULD SUGGEST A SERIOUS INJURY HAD OCCURRED DUE TO THE PRODUCT ISSUE. DURING THE TROUBLESHOOTING SESSION, IT WAS NOTED THAT THE REPORTED METER READINGS WERE 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. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGED INACCURACY ISSUE. HOWEVER, THERE IS NO EVIDENCE A SERIOUS INJURY HAD OCCURRED AS THE PATIENT'S SYMPTOMS PRECEDED THE ALLEGED ONSET OF THE PRODUCT ISSUE. IN ADDITION, THERE WAS NO MEDICAL INTERVENTION TO SUGGEST HYPERGLYCEMIA OR HYPOGLYCEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3090857

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR