BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2080019 · Received May 6, 2011

    Report

    Report Number
    2939301-2011-03731
    Event Type
    Injury
    Date Received
    May 6, 2011
    Report Date
    May 5, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AG
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: THE METER INVOLVED WITH THIS COMPLAINT FAILED TESTING. THE METER WAS FOUND TO HAVE A DEFECTIVE CAPACITOR. A SECONDARY ISSUE WAS NOTED, THE METER WAS FOUND TO HAVE A LOW/DEAD BATTERY. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Additional Manufacturer Narrative · 1

    THE 510 (K) # IS K053529. 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

    THE LAY USER / PATIENT CONTACTED LFS ON (B)(6) 2011 ALLEGING THAT THEIR ONE TOUCH ULTRA 2 METER DOES NOT POWER ON. THE PATIENT MENTIONED THAT THE METER STOPPED WORKING AROUND SEVEN MONTH AGO. DUE TO THE ALLEGED ISSUE, THE PATIENT WAS UNABLE TO TEST HIS BLOOD GLUCOSE AND CHANGED HIS DIET. AT AN UNSPECIFIED TIME AFTER THE ALLEGED ISSUE BEGAN, THE PATIENT DEVELOPED SYMPTOMS OF FEELING WEAK AND WAS TREMBLING. APPROXIMATELY 2 MONTHS AGO, THE PATIENT VISITED HIS PHYSICIAN AND WAS GIVEN DIFFERENT ORAL MEDICATIONS, SINCE HIS BLOOD GLUCOSE READINGS WERE "HIGH" AT THE PHYSICIAN'S OFFICE. NO FURTHER CLINICAL INFORMATION WAS PROVIDED ABOUT THE INCIDENT. THE PATIENT CHANGED THE BATTERY OVER THE PHONE WITH THE CUSTOMER CARE ADVOCATE (CCA) AND OBTAINED AN ERROR 1 MESSAGE. METER WAS REPLACED, SINCE THE ALLEGED ISSUE WAS NOT RESOLVED OVER THE PHONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 2939248

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Life Threatening| R