BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 1932319 · Received December 17, 2010

    Report

    Report Number
    2939301-2010-10844
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Report Date
    November 24, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP # 1/SUPPLEMENTAL REPORT TEXT-12/21/2010. 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 CRACKED/BROKEN DISPLAY. 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.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN 80CM TWO PORT THROUGH THE PEG JEJUNAL FEEDING TUBE (J-TUBE) WAS BEING USED FOR THE PURPOSE OF ADMINISTERING MEDICATION FOR ADVANCED STAGE PARKINSON'S DISEASE. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2010 THE PATIENT HAD NOTICED MOTORIC FLUCTUATIONS. AN X-TRAY WAS TAKEN ON (B)(6) 2010. THE PROCEDURE WAS COMPLETED A NEW TWO PORT THROUGH THE PEG JEJUNAL FEEDING TUBE (J-TUBE). ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    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 BLACK MARKS 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. 3067214

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR