BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 2112194 · Received June 3, 2011

    Report

    Report Number
    2939301-2011-04540
    Event Type
    Injury
    Date Received
    June 3, 2011
    Date of Event
    May 18, 2011
    Report Date
    May 20, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510 (K) # IS K073231. THE METER WAS RETURNED TO LFS FOR INVESTIGATION. WHILE INVESTIGATING THE METER IT WAS NOTED THAT THERE WAS AN EEPROM FAILURE AND PRODUCT ANALYSIS WAS UNABLE TO GET THE READINGS OFF THE METER DUE TO A DEFECTIVE EEPROM U6.

    Description of Event or Problem · 1

    THE LAY USER / PATIENT CONTACTED LFS ON (B)(6) 2011 ALLEGING AN ERROR 1 MESSAGE ON HER ONE TOUCH ULTRALINK METER. THE PATIENT MENTIONED THAT THE ALLEGED ISSUE WITH THE ERROR 1 MESSAGE BEGAN ON (B)(6) 2011 AT AROUND 9:00AM. DUE TO THE ALLEGED ERROR MESSAGE, THE PATIENT DID NOT TAKE ANY ACTION. APPROXIMATELY 4 HOURS LATER THE PATIENT DEVELOPED SYMPTOMS OF DEHYDRATION AND HAD "STICKY EYES". SHE DID NOT SEEK ANY FURTHER MEDICAL ATTENTION OR CONTACT THE PHYSICIAN FOR ASSISTANCE. THE PATIENT WAS NOT TESTED ON ANOTHER DEVICE. THE ALLEGED ISSUE WAS NOT RESOLVED OVER THE PHONE AND THE PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE ERROR 1 MESSAGE, SHE WAS UNABLE TO TEST AND LATER DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3094705

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Life Threatening