BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 4852495 · Received June 18, 2015

    Report

    Report Number
    2939301-2015-25305
    Event Type
    Injury
    Date Received
    June 18, 2015
    Report Date
    June 15, 2015
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K061118
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    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) 2015, THE LAY USER/PATIENT CONTACTED LIFESCAN (B)(4), ALLEGING THAT HER ONETOUCH ULTRAMINI METER READ INACCURATELY LOW. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT STATED THAT THE ALLEGED INACCURACY BEGAN ON (B)(6) 2015 (TIME NOT PROVIDED). THE PATIENT STATED THAT SHE OBTAINED THE RESULT OF "120 MG/DL" USING THE SUBJECT METER COMPARED TO RESULTS OF "450-600 MG/DL" OBTAINED USING A LAB DEVICE, THE TIME DIFFERENCE BETWEEN THE RESULTS WAS GREATER THAN 30 MINUTES. THE PATIENT MANAGES HER DIABETES WITH SELF-ADJUSTING INSULIN. THE PATIENT CONFIRMED THAT SHE DID NOT MAKE ANY CHANGES TO HER USUAL DIABETES MANAGEMENT REGIMEN IN RESPONSE TO THE ALLEGED PRODUCT ISSUE. THE PATIENT CLAIMED TO HAVE DEVELOPED THE SYMPTOM OF "DISORIENTATION" AT AN UNKNOWN DATE/TIME. THE PATIENT STATED THAT SHE VISITED HER DOCTORS OFFICE AND RECEIVED HCP TREATMENT OF 40 UNITS OF INSULIN ON (B)(6) 2015 AT 12:00PM. THE PATIENT DENIED THAT HER BLOOD GLUCOSE WAS TESTED USING ANOTHER DEVICE. AT THE TIME OF TROUBLESHOOTING, THE CSR NOTED THAT THE PATIENT WAS USING AN APPROVED SAMPLE SITE AND THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASURE SETTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSIONS: THE PATIENT RECEIVED HCP TREATMENT FOR A SEVERE HIGH BLOOD GLUCOSE EXCURSION AFTER THE ALLEGED INACCURACY BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396691 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3698648

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R