BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 1771752 · Received July 28, 2010

    Report

    Report Number
    2939301-2010-06014
    Event Type
    Malfunction
    Date Received
    July 28, 2010
    Report Date
    July 8, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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

    (B)(4). 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. SPC TEST PORT FOUND DIRTY. 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 ERROR 5 MESSAGE. 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

    DEVICE 1 OF 4. SEE MFR REPORT 1627487-2010-01532, 1627487-2010-01533 AND 1627487-2010-01534. THE PT RECEIVED THE SYSTEM CONSISTING OF AN IPG, A PADDLE LEAD AND TWO SINGLE EXTENSIONS ON (B)(6)2009. IT WAS REPORTED THAT THE PT LOST STIMULATION. AN X-RAY CONFIRMED THAT THE EXTENSIONS APPEARED TO HAVE PARTIALLY PULLED OUT OF THE IPG HEADERS AND HAD ALSO MIGRATED TO A LOWER POSITION. THE PT'S ENTIRE SYSTEM WAS EXPLANTED AND RETURNED TO THE MFR FOR EVAL. FOLLOW-UP ON THE PT FOUND NO FURTHER ISSUES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. 3006143

    Patients

    Seq Age Sex Outcome Treatment
    1