BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 3062148 · Received April 16, 2013

    Report

    Report Number
    3008382007-2013-08030
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Report Date
    April 9, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K082590
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    DEVICE EVALUATION: THE METER AND TEST STRIPS INVOLVED WITH THIS COMPLAINT HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 4/9/2013 AND 3/28/2013 RESPECTIVELY WITH THE FOLLOWING FINDINGS: THE METER AND TEST STRIP HAS PASSED TESTING. THE REPORTED ISSUE COULD NOT BE REPRODUCED. UNRELATED TO THE PRIMARY ISSUE, THE TEST STRIPS WERE FOUND TO HAVE AN ERROR 3 ISSUE. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED. DEVICE RETURNED TO MFG DATE: METER- 2/22/2013, TEST STRIPS- 3/27/2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163686 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR