BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 1810294 · Received August 20, 2010

    Report

    Report Number
    2939301-2010-07060
    Event Type
    Malfunction
    Date Received
    August 20, 2010
    Report Date
    August 15, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    MDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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

    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

    THE LAY USER/PATIENT CONTACTED LIFESCAN ALLEGING THE METER HAS BLACK MARKS IN THE DISPLAY. 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

    DURING USE OF THE DEVICE FOR A NON-CLINICAL ACTIVITY, THE USER REPORTED AN INTERMITTENT CF08 ERROR. NO OTHER DETAILS REGARDING THE NATURE OF THE EVENT WERE PROVIDED. SINCE THE EVENT OCCURRED DURING A NON-CLINICAL ACTIVITY, THERE WAS NO PT INVOLVEMENT DURING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT PING METER GLUCOSE MONITORING SYS/KIT MDS LIFESCAN, INC. 3017417

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR