BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 1900732 · Received November 16, 2010

    Report

    Report Number
    2939301-2010-09949
    Event Type
    Malfunction
    Date Received
    November 16, 2010
    Report Date
    November 1, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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; 510(K)# IS K082590.

    Additional Manufacturer Narrative · 1

    FOLLOW UP # 1/SUPPLEMENTAL REPORT TEXT-12/09/2010. THE LAY USER/PATIENT'S PRODUCT(S) HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED IN THIS CASE FAILED TESTING. THE METER WAS FOUND TO HAVE DATA CORRUPTION. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A SECOND FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED

    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 ERROR 1 WAS NOT RESOLVED WITH TROUBLESHOOTING.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PT EXPERIENCED EDEMA FOLLOWING THE IMPLANT PROCEDURE. THE PT'S CARDIOLOGIST DETERMINED THAT THE PT WAS ALLERGIC TO MORPHINE THAT WAS GIVEN TO THE PT FOR POST-PROCEDURAL PAIN. THE CARDIOLOGIST PRESCRIBED THE PT LASIX, AND THE PT IS NO LONGER EXPERIENCING EDEMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3050004

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR