BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 2213343 · Received August 16, 2011

    Report

    Report Number
    2939301-2011-07511
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 25, 2011
    Report Date
    August 2, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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. METER SERIAL #: NOT PROVIDED. TEST STRIP LOT #: NOT PROVIDED. THE 510K#: K073231.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN TO REPORT THE ONE TOUCH ULTRALINK METER WAS GIVING THE ERROR 3 ERROR MESSAGE. THE SR MEDICAL SURVEILLANCE SPECIALIST WAS ABLE TO CLASSIFY THE COMPLAINT BASED ON THE INFORMATION PROVIDED TO CUSTOMER SERVICE. ON (B)(6) 2011 AT 8:00 AM, THE PATIENT OBTAINED THE ERROR 3 ERROR MESSAGE ON THE REPORTED METER; SHE DID NOT OBTAIN A BLOOD GLUCOSE READING. AT 11:00 AM THE PATIENT EXPERIENCED THE SYMPTOMS OF BEING THIRSTY AND LETHARGIC. THE PATIENT TOOK THE ACTION OF TAKING A 1.5 UNIT BOLUS OF HUMALOG INSULIN VIA THE PUMP. SHE DID NOT SEEK ANY MEDICAL ATTENTION OR TREATMENT. NO INFORMATION WAS PROVIDED ABOUT THE TEST STRIPS OR TESTING TECHNIQUE. THE METER, TEST STRIPS AND CONTROL SOLUTION WERE REPLACED. THE PATIENT DID NOT SUFFER AN ADVERSE EVENT DUE TO THE REPORTED METER. THE PATIENT'S SYMPTOMS WERE NOT INDICATIVE OF SEVERE INJURY AND SHE DENIED SEEKING MEDICAL ATTENTION. HOWEVER, AS THE METER ERROR MESSAGE ISSUE WAS NOT RESOLVED, THIS COMPLAINT IS BEING REPORTED.

    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 42 YR