BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 1802007 · Received August 16, 2010

    Report

    Report Number
    2939301-2010-06659
    Event Type
    Malfunction
    Date Received
    August 16, 2010
    Report Date
    July 26, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    MDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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.

    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.

    Description of Event or Problem · 1

    THE LAY USER/PATIENT CONTACTED LIFESCAN ALLEGING THE METER DISPLAYS AN UNKNOWN ERROR MESSAGE. THE REPORTER STATED ERROR 13 DISPLAYED. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WERE NO ALLEGATIONS OF HARM OR INJURY. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, THE STENT GOT DAMAGED AND WAS EXPLANTED. THE TARGET LESION WAS LOCATED AT A SMALL BIFURCATION OF THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE PHYSICIAN WANTED TO PLACE ONE STENT IN THE MID LAD ARTERY AND PERFORM A "T STENTING" TECHNIQUE AND OPEN THE STENT TO THE BIFURCATION. A NON-BSC GUIDE WIRE WAS ADVANCED TO THE MID LAD AND A SECOND NON-BSC GUIDE WIRE WAS ADVANCED TO THE DAUGHTER BRANCH. WITHOUT PREDILATING, A 2.75X16MM PROMUS ELEMENT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE MID LAD AND THE STENT WAS DEPLOYED AT 18 ATMS FOR 30 SECONDS. ANGIOGRAPHY REVEALED EXCELLENT STENT APPOSITION. NEXT, A NON-BSC GUIDE WIRE WAS ADVANCED THROUGH THE STENT TO THE DAUGHTER VESSEL AND THE PHYSICIAN WANTED TO REMOVE THE EXISTING NON-BSC GUIDE WIRE. HOWEVER, THERE WAS SLIGHT RESISTANCE WHEN REMOVING THE EXISTING GUIDE WIRE AND THE PROMUS ELEMENT STENT BECAME DEFORMED AND WAS PULLED TO THE LEFT MAIN. THE STENT WAS UNDERSIZED AND COULD NOT BE DEPLOYED IN THE LEFT CIRCUMFLEX SO THE PHYSICIAN REMOVED THE STENT USING A LASSO TECHNIQUE. THE PROCEDURE WAS COMPLETED WITH A NON-BSC STENT WHICH WAS POST DILATED WITH THE KISSING BALLOON TECHNIQUE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. THIS PRODUCT IS ONLY OUS APPROVED, BUT IT IS SIMILAR TO AN APPROVED UNITED STATES DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT PING METER GLUCOSE MONITORING SYS/KIT MDS LIFESCAN, INC. 3020721

    Patients

    Seq Age Sex Outcome Treatment
    1