BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRASMART METER

    MDR report key: 2815689 · Received November 1, 2012

    Report

    Report Number
    2939301-2012-12564
    Event Type
    Injury
    Date Received
    November 1, 2012
    Report Date
    October 11, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    PMA / PMN Number
    K021819
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH ULTRASMART METER READ INACCURATELY HIGH. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN THE FIRST WEEK OF (B)(6) 2012. THE PATIENT REPORTED BLOOD GLUCOSE RESULTS OF "112, 150, 160, 212 AND 290 MG/DL" WITH THE SUBJECT METER. THE PATIENT ALSO REPORTED BLOOD GLUCOSE RESULTS "30-50 POINTS HIGHER" ON THE SUBJECT METER COMPARED TO HER OTHER METER WHICH SHE PREFERS TO USE. THE PATIENT MANAGES HER DIABETES WITH ORAL MEDICATIONS (TYPE/ AMOUNT NOT SPECIFIED). IT IS NOT KNOWN IF THE PATIENT MADE CHANGES TO HER USUAL DIABETES MANAGEMENT ROUTINE. AN HOUR AFTER THE START OF THE ALLEGED ISSUE, THE PATIENT CLAIMS SHE FELT LIGHT HEADED, JITTERY, DIZZY AND SHAKY. THE PATIENT WAS GIVEN FOOD AND/ OR DRINK AS TREATMENT. ON (B)(6) 2012, THE PATIENT REPORTEDLY OBTAINED BLOOD GLUCOSE RESULTS "30-40 POINTS" LOWER ON ANOTHER METER. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT AND EDUCATED THE PATIENT ON APPROVED SAMPLE SITES FOR TESTING. THE CCA WAS NOT ABLE TO WALK THE PATIENT THROUGH QUALITY CONTROL TESTING. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRASMART METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3352186

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Life Threatening| R