BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 1850749 · Received October 1, 2010

    Report

    Report Number
    2939301-2010-08759
    Event Type
    Malfunction
    Date Received
    October 1, 2010
    Report Date
    September 28, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    MDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENT'S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED IN THIS CASE HAS PASSED TESTING WITH NO FAULTS FOUND. 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

    THE LAY USER/PATIENT WAS ALLEGING THAT A CONTROL SOLUTION TEST FELL ABOVE THE RANGE; HOWEVER, THE PATIENT DID NOT SPECIFY THE RESULT. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WERE NO ALLEGATIONS OF HARM OR INJURY. REPLACEMENT METER AND TEST STRIPS WERE SENT TO THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL DUODENAL STENT WAS IMPLANTED IN THE DUODENUM OF A CANCER PATIENT ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT THE PATIENT HAD A BLOCKAGE IN THE FIRST AND SECOND PART OF THE DUODENUM AS A RESULT OF CANCER. THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE GUIDE WIRE WAS ADVANCED ACROSS THE STRICTURE AND THE LENGTH WAS APPROXIMATED TO BE FOUR AND A HALF CENTIMETERS. THE PHYSICIAN THEN CHOSE A NINE CENTIMETER STENT. AFTER THE STENT WAS DEPLOYED AND FULLY EXPANDED, IT WAS OBSERVED UNDER FLUOROSCOPY THAT THE LENGTH OF THE STENT WAS NOT MORE THEN SEVEN AND A HALF CENTIMETERS. NO ACTION WAS TAKEN TO REMOVE THE STENT, FOR IT WAS COVERING THE STRICTURE. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION POST PROCEDURE WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT PING METER GLUCOSE MONITORING SYS/KIT MDS LIFESCAN, INC. 2934640

    Patients

    Seq Age Sex Outcome Treatment
    1