BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT SELECT METER

    MDR report key: 2110586 · Received June 1, 2011

    Report

    Report Number
    2939301-2011-04504
    Event Type
    Injury
    Date Received
    June 1, 2011
    Date of Event
    May 14, 2011
    Report Date
    May 15, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE (K) # IS K072543. THE METER CAME BACK FOR INVESTIGATION AND IT WAS NOTED THAT THE METER PASSED TESTING. THIS WAS A NEW METER AND THERE WERE NOT READINGS IN THE METER MEMORY. THE REPORTED ISSUE WAS NOT CONFIRMED.

    Description of Event or Problem · 1

    THE LAY USER / PATIENT CONTACTED LFS ON (B)(6) 2011 ALLEGING AN ERROR 2 MESSAGE ON THE PATIENT'S ONE TOUCH SELECT METER. THE PATIENT MENTIONED THAT THE ALLEGED ISSUE BEGAN ON (B)(6) 2011 AT AROUND 2:30AM. DUE TO THE ALLEGED ISSUE THE PATIENT WAS UNABLE TO TEST HIS BLOOD GLUCOSE. THE PATIENT DID NOT TAKE ANY ACTION AFTER OBTAINING THE ALLEGED ERROR 2 MESSAGE. AT AROUND 5:30PM THAT EVENING, THE PATIENT BEGAN SWEATING. THE PATIENT DID NOT SEEK ANY MEDICAL ATTENTION OR CONTACT HIS PHYSICIAN FOR ASSISTANCE. THIS WAS THE FIRST TIME THE PATIENT WAS USING THE PRODUCT. WHILE TROUBLESHOOTING, IT WAS NOTED THAT THE PATIENT WAS USING ONE TOUCH ULTRA TEST STRIPS. THE ULTRA TEST STRIPS DO NOT WORK WITH THE SELECT METER. THE PATIENT NEEDS TO USE SELECT TEST STRIPS. THE PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE ALLEGED ERROR 2 MESSAGE, THE PATIENT LATER DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT SELECT METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3135723

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Life Threatening