BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 1904682 · Received November 22, 2010

    Report

    Report Number
    2939301-2010-10111
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Report Date
    November 4, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP # 1/SUPPLEMENTAL REPORT TEXT-12/01/2010. 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 THAT THE COPILOT CAP COULD NOT BE LOCKED TIGHTLY, RESULTING IN AIR ENTERING THE SYSTEM, AND A SMALL AMOUNT OF AIR INTO THE PATIENT'S VESSEL DURING THE PERCUTANEOUS CORONARY INTERVENTION. THERE WERE NO ADVERSE EFFECTS DUE TO THE LEAKING OF AIR INTO THE VESSEL. THE PHYSICIAN STOPPED THE PROCEDURE AND FOUND A LOT OF AIR IN THE LUMEN OF THE COPILOT. THE COPILOT WAS REPLACED WITH A NEW ONE AND THE PROCEDURE CONTINUED. NO PATIENT EFFECTS WERE REPORTED. PATIENT HEALTH STATUS IS FINE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    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. 3047542

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR