BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRASMART METER

    MDR report key: 1001981 · Received February 21, 2008

    Report

    Report Number
    2939301-2008-00216
    Event Type
    Injury
    Date Received
    February 21, 2008
    Date of Event
    January 31, 2008
    Report Date
    January 31, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER AND STRIPS FOR EVALUATION, BUT HAS NOT YET RECEIVED THEM. IF EITHER THE METER OR STRIPS ARE RETURNED, LIFESCAN WILL EVALUATE IT/THEM AND, IF EITHER THE METER OR STRIPS DO NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IN 2008, THE LAY PT'S WIFE CONTACTED LIFESCAN (LFS) ALLEGING THAT THE PT'S ONE TOUCH ULTRA SMART METER DISPLAYED THE ERROR 5 MESSAGE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION SINCE THE MEDICAL AFFAIRS SPECIALIST (MAS) WAS UNABLE TO CONTACT THE PT TO OBTAIN ADDITIONAL INFO. THE WIFE SAID SHE TESTED THE PT'S BLOOD GLUCOSE AND RECEIVED A READING OF 575 MG/DL; THE TEST TIME WAS UNSPECIFIED. SHE THEN GAVE THE PT A SHOT OF INSULIN (TYPE AND DOSE NOT PROVIDED). THE WIFE NOTICED THAT THE PT WAS MAKING WEIRD SOUNDS AND HE WOULD NOT RESPOND TO HER. SHE ATTEMPTED TO TEST THE PT'S BLOOD GLUCOSE WITH THE REPORTED PRODUCT AND RECEIVED THE ERROR 5 MESSAGE. THE WIFE CALLED EMS AT 10:30 PM ON THE SAME DAY. EMT'S OBTAINED A RESULT DESCRIBED AS "VERY LOW". AN IV WAS STARTED AND LATER A BLOOD GLUCOSE RESULT OF 247 MG/DL WAS OBTAINED. THE CCA WALKED THE WIFE THROUGH TESTING WITH A NEW VIAL OF TEST STRIPS AND RESOLVED THE ISSUE. THE PT'S PRODUCT WERE REPLACED. THE COMPLAINT IS REPORTED BECAUSE THE REPORTER ALLEGES THAT THE PT BECAME UNRESPONSIVE AFTER RECEIVING INSULIN BASED ON A HYPERGLYCEMIC READING ON THE LFS PRODUCT. THE REPORTER CLAIMS SHE RECEIVED AN ERRROR 5 MESSAGE PRIOR TO CALLING EMS AND THE PT RECEIVED IV TREATMENT FOR A LOW BLOOD GLUCOSE LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRASMART METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2753922

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Life Threatening| R