BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 2350256 · Received November 28, 2011

    Report

    Report Number
    2939301-2011-11551
    Event Type
    Malfunction
    Date Received
    November 28, 2011
    Report Date
    October 25, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510(K) # IS K080639.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED LIFESCAN ON (B)(6) 2011 TO REPORT AN "ERROR 4" ISSUE WITH THE SUBJECT METER. THE CUSTOMER SERVICE REPRESENTATIVE WALKED THE REPORTER THROUGH TROUBLESHOOTING AND THE REPORTER WAS ABLE TO PERFORM A SUCCESSFUL TEST. THERE WAS NO ALLEGATIONS OF HARM OR INJURY AS A RESULT OF THE REPORTED ISSUE. THERE WAS ALSO NO INDICATION THAT THE SUBJECT METER MALFUNCTIONED AT THE TIME OF TROUBLESHOOTING WITH CUSTOMER SERVICE. LIFESCAN HAS RECEIVED THE METER INVOLVED WITH THIS COMPLAINT AND COMPLETED DEVICE EVALUATION ON (B)(6) 2011. INVESTIGATION REVEALED THAT THE SPC PINS WERE HIGH AND OUT OR SPECIFICATIONS. THIS COMPLAINT IS NOW BEING REPORTED DUE TO THE FAILED DEVICE EVALUATION RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3174445

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR