BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 2220192 · Received August 23, 2011

    Report

    Report Number
    2939301-2011-07851
    Event Type
    Injury
    Date Received
    August 23, 2011
    Report Date
    August 5, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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.THE 510(K) # IS K073231.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT'S HUSBAND CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS WIFE'S ONETOUCH ULTRALINK METER WAS READING INACCURATELY HIGH COMPARED TO ANOTHER DEVICE. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/PATIENT FOR FOLLOW-UP QUESTIONS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT'S HUSBAND REPORTED THE ALLEGED ISSUE WITH THE SUBJECT METER BEGAN ON AN UNSPECIFIED DAY AT EVENING TIME. REPORTEDLY, THE PATIENT OBTAINED AN UNKNOWN GLUCOSE RESULT ON THE SUBJECT METER, WHICH WAS "40 MG/DL" POINTS HIGHER THAN ANOTHER METER, DONE WITHIN 30 MINUTES OF EACH OTHER. THE REPORTER STATED THAT THE PATIENT MANAGES HER DIABETES WITH INSULIN (SELF ADJUSTER), AND DUE TO THE ALLEGED INACCURATE HIGH RESULT, SHE INCREASED HER DOSE OF INSULIN (UNKNOWN DOSE OR TYPE). THE PATIENT'S HUSBAND CLAIMED THE NEXT MORNING AT AN UNSPECIFIED TIME, SHE OBTAINED A RESULT OF "30 MG/DL" ON AN UNSPECIFIED METER, AND SHE FELT SWEATY AND HAD DIFFICULTY BREATHING. IT IS UNKNOWN IF THE PATIENT RECEIVED ANY MEDICAL TREATMENT DUE TO HER SYMPTOMS. DURING THE INITIAL CALL WITH CUSTOMER SERVICE, THE AGENT NOTED THAT THE PATIENT WAS USING AN APPROPRIATE SAMPLE SITE AND THE METER SET TO THE CORRECT UNIT OF MEASURE. PATIENT'S HUSBAND DECLINED REPLACEMENT OF PRODUCTS. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT'S HUSBAND CLAIMS THE PATIENT OBTAINED AN INACCURATE HIGH READING ON THE SUBJECT METER, ADMINISTERED TREATMENT BASED ON THE ALLEGED RESULT, AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3151896

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening