BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 1900713 · Received November 16, 2010

    Report

    Report Number
    2939301-2010-09941
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP # 1/SUPPLEMENTAL REPORT TEXT 12/02/2010. 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

    IT WAS FURTHER REPORTED THAT THE DIFFICULTIES WERE ENCOUNTERED DURING THE PROCEDURE, CORRECTED FROM THE ORIGINALLY REPORTED PLATFORMING. THE KNOB "RETURNED A LITTLE AUTOMATICALLY" WHEN THE KNOB WAS TURNED TO MAX. THERE WAS NO SPEED DIFFERENCE WHEN THE KNOB RETURNED. THE LESION BEING TREATED WAS LOCATED IN THE LEFT MAIN, AND THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WAS NO PATIENT CONSEQUENCE.

    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 ERROR 1 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. 3039530

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR