BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 2018222 · Received March 14, 2011

    Report

    Report Number
    2939301-2011-02172
    Event Type
    Injury
    Date Received
    March 14, 2011
    Date of Event
    February 16, 2011
    Report Date
    February 16, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    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. 510(K) # IS K062195.

    Additional Manufacturer Narrative · 1

    PRODUCTS STILL HAVE NOT BEEN RETURNED. RETAIN TEST STRIPS WERE TESTED AND THE RETAIN TEST STRIPS PASSED TESTING. ORIGINAL MEDWATCH THE INFORMATION WAS MISSING . PT IS FEMALE AND EVENT SHOULD BE CHECKED MARKED AS LIFE- THREATENING.

    Description of Event or Problem · 1

    ON (B)(6) 2011 THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRA METER WAS READING INACCURATELY ERRATIC. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/PATIENT FOR FOLLOW-UP QUESTIONS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE BEGAN ON (B)(6) 2011 AT 12:32PM. THE PATIENT REPORTED BLOOD GLUCOSE READINGS OF "182, 206, 168, AND 176 MG/DL" WITH THE SUBJECT METER, PERFORMED WITHIN 20 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS DO NOT EXCEED THE EXPECTED VALUE OF <= 20% AND/OR <= 20 MG/DL. THE PATIENT CLAIMED SHE MANAGES HER DIABETES WITH PILLS AND DIET/EXERCISE. DUE TO THE ALLEGED ISSUE, THE PATIENT DENIED TAKING ANY ACTION REGARDING HER DIABETES MANAGEMENT. THE PATIENT CLAIMED SHE FELT SWEATY A MINUTE OR TWO AFTER THE ALLEGED ISSUE BEGAN. IN SPITE OF HER SYMPTOM, THE PATIENT DENIED RECEIVING ANY MEDICAL TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE RESULTS WERE FROM THE SAME APPROVED SAMPLE SITE AND THE SUBJECT METER'S UNIT OF MEASURE WAS SET CORRECTLY. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. IT IS NOT KNOWN WHETHER THE PATIENT ASSOCIATED HER SYMPTOM AS HIGH OR LOW BLOOD SUGAR SYMPTOMS. THEREFORE, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED A SYMPTOM SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3072105

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR