BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRASMART METER

    MDR report key: 2116879 · Received June 8, 2011

    Report

    Report Number
    2939301-2011-04713
    Event Type
    Injury
    Date Received
    June 8, 2011
    Date of Event
    May 28, 2011
    Report Date
    May 28, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510 (K) # IS K021819. ADDITIONAL LOT # USED BY THE PATIENT THAT SHE HAD OBTAINED THE ALLEGED ERROR 5 MESSAGE: 3136004; 3092033. 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.

    Description of Event or Problem · 1

    THE LAY USER/PATIENT CONTACTED LFS ON (B)(6) 2011 ALLEGING AN ERROR 5 MESSAGE ON HER ONE TOUCH ULTRASMART METER. THE PATIENT MENTIONED THAT SHE HAD TRIED SEVERAL LOT NUMBERS OF TEST STRIPS AND THE ISSUE PERSISTED. THE PATIENT MENTIONED THAT THE ALLEGED ISSUE WITH THE ERROR 5 MESSAGE BEGAN ON (B)(6) 2011 AT AROUND 12:30PM. APPROXIMATELY 15 MINUTES LATER THE PATIENT DEVELOPED SYMPTOMS OF FEELING DISORIENTED AND "JERKY". THE PATIENT ATE MORE FOOD/DRINK AND DID NOT SEEK ANY FURTHER MEDICAL ATTENTION OR CONTACT HER PHYSICIAN FOR ASSISTANCE. THIS IS NOT THE FIRST TIME THE PRODUCT IS BEING USED. THE TECHNIQUE OF APPLYING BLOOD ON THE TEST STRIP WAS CORRECT. THE TEST STRIPS WERE IN GOOD CONDITION AND NOT EXPIRED. THIS IS NOT THE FIRST TIME THE PRODUCT IS BEING USED. THE ALLEGED ISSUE WAS NOT RESOLVED OVER THE PHONE. THE PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE ALLEGED ERROR MESSAGE. SHE WAS UNABLE TO TEST AND LATER DEVELOPED SYMPTOM SUGGESTIVE OF A SERIOUS INJURY AND HAD TO SELF-TREAT WITH FOOD/DRINK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRASMART METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3136004

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Life Threatening| R