BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 1880790 · Received October 25, 2010

    Report

    Report Number
    2939301-2010-09389
    Event Type
    Malfunction
    Date Received
    October 25, 2010
    Report Date
    October 19, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP # 1/SUPPLEMENTAL REPORT TEXT-(B)(4) 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 INCORRECT SETTINGS. 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 DURING A ROUTINE REPLACEMENT OF THE SECURI-T PERCUTANEOUS DEVICE, ON SEPTEMBER 21, 2010, THE INTERNAL BOLSTER DETACHED INSIDE THE PATIENT'S STOMACH WHILE BEING REMOVED. THE DEVICE HAD BEEN PLACED APPROXIMATELY SIX MONTHS PREVIOUSLY. THE PHYSICIAN WAS NOT CONCERNED ABOUT THE DETACHMENT OF THE DEVICE FRAGMENT AS HE FELT THE FRAGMENT WOULD PASS NATURALLY. THE PROCEDURE WAS COMPLETED WITH A NEW SECURI-T PERCUTANEOUS REPLACEMENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    THE LAY USER/PATIENT CONTACTED LIFESCAN ALLEGING THE METER HAS A CONTRAST ISSUE. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WERE NO ALLEGATIONS OF HARM OR INJURY. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. 3033918

    Patients

    Seq Age Sex Outcome Treatment
    1