BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 1900815 · Received November 16, 2010

    Report

    Report Number
    2939301-2010-09958
    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
    VA, 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

    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.

    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.

    Description of Event or Problem · 1

    SAME CASE AS MFR ID#: 2134265-2010-04718. IT WAS REPORTED THAT DURING AN ANGIOPLASTY TREATMENT PROCEDURE, A BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIAL TIBIAL ARTERY. A 1.5MMX20MMX142CM STERLING ES BALLOON CATHETER WAS ADVANCED TO THE TARGET LESION. UPON THE FIRST INFLATION, THE BALLOON RUPTURED AT 6ATM. THE DEVICE WAS REMOVED INTACT, AND A 2.0MMX40MMX145CM STERLING ES BALLOON WAS ADVANCED. UPON THE FIRST INFLATION, THE BALLOON ALSO RUPTURED AT 6ATM. THE DEVICE WAS REMOVED INTACT AND THE PROCEDURE WAS COMPLETED WITH A STERLING ES 2.5MMX40MM AND STERLING ES 3MMX40MM. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3010053

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR