BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 1993951 · Received February 16, 2011

    Report

    Report Number
    2939301-2011-01409
    Event Type
    Injury
    Date Received
    February 16, 2011
    Date of Event
    January 25, 2011
    Report Date
    January 27, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 HIS ONETOUCH ULTRALINK METER READ INACCURATELY. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN ON (B)(6) 2011 AT 745PM. THE PATIENT REPORTED BLOOD GLUCOSE RESULTS OF "567, 60, 347 AND 40 MG/DL" WITH THE SUBJECT METER. THE CCA WAS ADVISED THE PATIENT MANAGES HIS DIABETES WITH INSULIN. THE PATIENT STATED HE TOOK 8 UNITS NOVOLOG INSULIN WHEN HIS BLOOD GLUCOSE READ "567 MG/DL." ABOUT 30-45 MINUTES LATER, THE PATIENT CLAIMED HE "LOST CONSCIOUSNESS" AND HIS WIFE CONTACTED EMERGENCY MEDICAL SERVICES (EMS). PRIOR TO EMS ARRIVING, THE PATIENT TRIED TO TAKE FOOD AND/ OR DRINK A BEVERAGE. ABOUT 10PM-11PM, THE PATIENT OBTAINED A BLOOD GLUCOSE RESULT OF "20 MG/DL" ON THE EMS METER AND WAS GIVEN GLUCOSE TABLETS/ GLUCOSE GEL AS TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT AND AN APPROVED SAMPLE SITE WAS USED FOR TESTING. THE PATIENT DID NOT HAVE CONTROL SOLUTION TO TEST THE SUBJECT METER. 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, ADMINISTERED TREATMENT BASED ON THE ALLEGED RESULT, AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AND RECEIVED MEDICAL INTERVENTION FROM A HEALTH CARE PROFESSIONAL (HCP) 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. 3089041

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Life Threatening| R