BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 2023892 · Received March 18, 2011

    Report

    Report Number
    2939301-2011-02357
    Event Type
    Injury
    Date Received
    March 18, 2011
    Date of Event
    March 2, 2011
    Report Date
    March 2, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONETOUCH ULTRALINK METER WAS READING INACCURATELY HIGH COMPARED TO FEELING/NORMAL RESULT(S). THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED HE OBTAINED AN ALLEGED READING OF "149 MG/DL" WITH THE SUBJECT METER THAT BEGAN ON (B)(6) 2011 AT 11:09AM. AS PART OF HIS DIABETES REGIMEN, THE PATIENT CLAIMED HE IS ON AN INSULIN PUMP. DUE TO THE ALLEGED ISSUE, THE PATIENT STATED NO ACTION WAS TAKEN REGARDING HIS DIABETES REGIMEN. THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS OF SHAKINESS, A HEADACHE, TINGLING IN THE HAIR, AND FEET BEGAN TO HURT 2 HOURS AND 47 MINUTES AFTER THE ALLEGED ISSUE BEGAN. IN RESPONSE TO HIS SYMPTOMS, THE PATIENT INDICATED HE ADMINISTERED GLUCOSE TABLETS/GLUCOSE GEL. ACCORDING TO THE PATIENT, NO OTHER BLOOD GLUCOSE DEVICE WAS USED AT THE TIME OF THE ALLEGED ISSUE. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE SUBJECT METER'S UNIT OF MEASURE WAS SET CORRECTLY. THE PATIENT DID NOT HAVE THE CONTROL SOLUTION TO PERFORM A QUALITY CONTROL TEST. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS HE OBTAINED AN INACCURATE HIGH READING ON THE SUBJECT METER 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. 3057858

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Life Threatening| R