BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 2042693 · Received April 6, 2011

    Report

    Report Number
    2939301-2011-02865
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    March 28, 2011
    Report Date
    March 31, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (05/23/2011)-DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: THE METER HAS PASSED TESTING WITH NO FAULTS FOUND. 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 K061118. 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 THEY WERE UNABLE TO TEST ON THEIR ULTRAMINI METER. WHILE TROUBLESHOOTING, IT WAS NOTED THAT THE PATIENT WAS TESTING IN THE SETTINGS MODE. THE PATIENT MENTIONED THAT THE ALLEGED ISSUE BEGAN ON (B)(6) 2011. DUE TO THE ALLEGED ISSUE, THE PATIENT WAS UNABLE TO TEST AND THE FOLLOWING DAY DEVELOPED SYMPTOMS OF FEELING SHAKY AND DIZZY. THE PATIENT SAW THE PHYSICIAN IN THE URGENT CARE ON (B)(6) 2011 AND WAS TREATED WITH INSULIN. THE PATIENT WAS NOT TESTED ON ANOTHER DEVICE. THE PATIENT WAS UNABLE/UNWILLING TO TEST USING THE CORRECT TESTING PROCEDURE TO SEE IF THE ALLEGED ISSUE WAS RESOLVED OVER THE PHONE. THE PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT THEY WERE UNABLE TO TEST AND DUE TO THE ALLEGED ISSUE THE PATIENT DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AND HAD TO BE TREATED WITH INSULIN BY THEIR PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3117850

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Life Threatening| R