BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 1820294 · Received August 30, 2010

    Report

    Report Number
    2939301-2010-07297
    Event Type
    Malfunction
    Date Received
    August 30, 2010
    Report Date
    August 18, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    MDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 A DEFECTIVE LCD. 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 A LINE THROUGH 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

    IT WAS INITIALLY REPORTED BY A PATIENT'S MOTHER THAT THE VNS PATIENT EXPERIENCED AN INCREASE IN SEIZURE INTENSITY AND NOTED THE VNS MAGNET NOT WORKING TO SHORTEN SEIZURES. THE TREATING NURSE RELATED THE EVENTS TO END OF SERVICE OF THE GENERATOR. A BATTERY LIFE CALCULATION WAS PERFORMED AND INDICATED .22 YEARS UNTIL EOS=YES. MOREOVER, THE PATIENT UNDERWENT GENERATOR REPLACEMENT SURGERY DUE TO END OF SERVICE. THE EXPLANTED GENERATOR WAS RETURNED TO THE MANUFACTURER AND UNDERWENT ANALYSIS. ANALYSIS OF THE GENERATOR REVEALED THE END OF SERVICE CONDITION WAS NOT CONFIRMED. AT THE MOMENT, GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE TREATING NEUROLOGIST HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1