BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 2162929 · Received July 15, 2011

    Report

    Report Number
    2939301-2011-05822
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Report Date
    June 17, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS/HAVE BEEN RETURNED TO LIFESCAN. HOWEVER, PRODUCT ANALYSIS WAS NOT REQUIRED FOR THE METER IN RELATION TO THIS COMPLAINT SINCE THE ALLEGATION WAS A MISSING CABLE. 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

    THERE IS NO TEST TO CONFIRM WHETHER THE PRODUCT WAS MISSING FROM THE PACKAGE. THIS COMPLAINT IS BEING SUBMITTED BASED ON THE USER'S ALLEGATION. 510(K)# IS K082590.

    Description of Event or Problem · 1

    THERE IS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE MISSING PRODUCT WAS NOT RESOLVED WITH TROUBLESHOOTING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR