BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 2517645 · Received April 5, 2012

    Report

    Report Number
    2939301-2012-03336
    Event Type
    Injury
    Date Received
    April 5, 2012
    Date of Event
    March 29, 2012
    Report Date
    March 29, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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 510K#: K073231.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY USER/PATIENT IN (B)(6) CONTACTED LIFESCAN TO REPORT THE ONE TOUCH ULTRALINK METER WAS GIVING THE ERROR 2 ERROR MESSAGE UPON TEST STRIP INSERTION. THE SR. MEDICAL SURVEILLANCE SPECIALIST WAS ABLE TO CLASSIFY THE COMPLAINT BASED ON THE INFORMATION PROVIDED TO CUSTOMER SERVICE. ON (B)(6) 2012 AT 1:00 PM, THE PATIENT OBTAINED THE ERROR MESSAGE ERROR 2 ON THE REPORTED METER WHEN THE TEST STRIP WAS INSERTED; SHE WAS UNABLE TO OBTAIN A BLOOD GLUCOSE READING. THE PATIENT TOOK NO ACTIONS DUE TO THIS METER ISSUE. AT 11:00 PM THE PATIENT EXPERIENCED THE SYMPTOMS OF SHAKING, SWEATING AND DISORIENTATION. THE PATIENT DID NOT SEEK ANY MEDICAL ATTENTION OR TREATMENT. THE PATIENT MANAGES HER DIABETES WITH AN INSULIN PUMP. TROUBLESHOOTING REVEALED THE PATIENT'S TEST STRIPS WERE CORRECT, AND THE ERROR MESSAGE DID NOT OCCUR WITH PRESSING THE POWER BUTTON. THE METER, TEST STRIPS AND CONTROL SOLUTION WERE REPLACED. THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS SUGGESTING SEVERE HYPOGLYCEMIA AFTER SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE LEVEL DUE TO THE METER ERROR MESSAGE ISSUE. THEREFORE 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. 3269559

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening