BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 2231907 · Received September 1, 2011

    Report

    Report Number
    2939301-2011-08508
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Report Date
    April 4, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510(K) # IS K082590.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE REPORTER CONTACTED LIFESCAN ALLEGING AN UNSPECIFIED ERROR MESSAGE WITH THE SUBJECT METER. THE REPORTED ISSUE WAS RESOLVED WITH CUSTOMER SERVICE TROUBLESHOOTING. THERE WERE NO ALLEGATIONS OF HARM OR INJURY. BASED ON THE CUSTOMER SERVICE INVESTIGATION, THIS COMPLAINT IS NOT REPORTABLE SINCE THERE WAS NO EVIDENCE OF A MALFUNCTION OR ADVERSE EVENT. ON (B)(6) 2011 THE METER INVOLVED WITH THIS COMPLAINT WAS RETURNED TO LIFESCAN AND WAS EVALUATED BY THE PRODUCT ANALYSIS GROUP. INVESTIGATION FOUND THAT THE METER'S SPC PINS WERE ABOVE SPECIFICATIONS AND WERE ALSO BENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FAILED DEVICE INVESTIGATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3090111

    Patients

    Seq Age Sex Outcome Treatment
    1