BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 1871738 · Received October 15, 2010

    Report

    Report Number
    2939301-2010-09120
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Report Date
    October 9, 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

    FOLLOW UP # 1/SUPPLEMENTAL REPORT TEXT 12/07/2010. 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 REPORTED, THE TARGETER IS OLD, AND EVERYTHING PROCEEDED NORMALLY. THE NAIL WAS PASSED CORRECTLY, THE LAG SCREW WAS INSERTED, AND ON INSERTION OF THE DISTAL SCREW, THE DRILL MISSED THE NAIL, THROUGH THE GUIDE AND SCREW WAS PLACED POSTERIOR TO THE NAIL. REMOVED THE SCREW, TRIED TO REDRILL THROUGH THE GUIDE, AND THE DRILL BIT SHATTERED INSIDE THE NAIL. HAD TO REMOVE THE FAILED GAMMA III GUIDE, AND COMPLETED FREEHAND. AFTER SURGERY, REP LOOKED AT IT TO SEE HOW IT LOOKS, THERE WAS JUST SO MUCH PLAY IN IT. THE SHATTERED DRILL BIT WAS REMOVED, BUT PARTICLES WERE LEFT INSIDE.

    Description of Event or Problem · 1

    THE LAY USER/PATIENT CONTACTED LIFESCAN ALLEGING THE METER DOES NOT POWER ON BY PRESSING BUTTONS. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WERE NO ALLEGATIONS OF HARM OR INJURY. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1