BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 4150655 · Received October 8, 2014

    Report

    Report Number
    2939301-2014-26706
    Event Type
    Injury
    Date Received
    October 8, 2014
    Report Date
    September 30, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ¿ (02/14/2015). THE PATIENT¿S METER HAS BEEN RETURNED ON 1/27/2015 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 2/2/2015 WITH THE FOLLOWING FINDINGS:THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE CONFIRMED. A DHR (DEVICE HISTORY RECORD) WAS COMPLETED ON 12/12/2014 FOR THIS PRODUCT AND NO DEVIATIONS, NON-CONFORMANCES, OR REWORKS WERE OBSERVED. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2014 THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT THE ¿UP ARROW¿ BUTTON ON THEIR ONETOUCH ULTRA METER WAS STUCK/STICKING. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT ALLEGED THAT THE REPORTED ISSUE BEGAN ON (B)(6) 2014 AT 8:30AM. THE PATIENT DOES NOT CURRENTLY TAKE ANY MEDICATION FOR THEIR DIABETES AND DENIED MAKING ANY CHANGES TO THIS ROUTINE IN RESPONSE TO THE ALLEGED PRODUCT ISSUE. THE PATIENT REPORTED DEVELOPING A SYMPTOM OF ¿SHAKING¿ RIGHT AFTER THE PRODUCT ISSUE BEGAN. THE PATIENT DENIED RECEIVING ANY TREATMENT FOR THIS SYMPTOM. THE ALLEGED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT DEVELOPED A SERIOUS SYMPTOM AFTER THE ALLEGED PRODUCT ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632852 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3583151

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Life Threatening