BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 1843202 · Received September 23, 2010

    Report

    Report Number
    2939301-2010-08376
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Report Date
    September 16, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    MDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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; 510 (K) # IS K082590.

    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

    A PATIENT CONTACTED OUR (B)(4) AFFILIATE TO REPORT DEVELOPING A CORNEAL ULCER WHILE WEARING 1-DAY ACUVUE TRUEYE CONTACT LENSES, NARAFILCON A. NARAFILCON A LENSES ARE NOT MARKETED IN THE U.S. THE PATIENT SAID HE/SHE WAS DIAGNOSED WITH A CORNEAL ULCER. THE TREATING ECP, WHO DID NOT FIT THE PATIENT WITH 1-DAY TRUEYE LENSES, TOLD THE PATIENT THAT THE CONTACT LENSES MAY NOT HAVE FIT CORRECTLY. A FACE TO FACE INTERVIEW AT THE TREATING CLINIC PROVIDED THE FOLLOWING INFORMATION: ON (B)(6) 2010, THE PATIENT PRESENTED TO THE CLINIC COMPLAINING OF OD PAIN, REDNESS, WATERY EYE AND PHOTOPHOBIA. THE PATIENT WAS FOUND TO HAVE A 1 MM X 1 MM CORNEAL INFILTRATE AT THE OD SUPERIOR LIMBUS. THE INFILTRATE WAS CIRCULAR IN SHAPE. THE INFILTRATE WAS DETERMINED TO BE INFECTIOUS; A CULTURE WAS NOT PERFORMED. THE PATIENT'S VA WAS 1.5 AND WAS NOT AFFECTED. THE PATIENT WAS TREATED WITH BESTRON EYE DROPS, TARIVID EYE OINTMENT AND HYALEIN EYE DROPS. ON (B)(6) 2010, THE PATIENT RETURNED TO THE CLINIC, "THE INFILTRATE MUCH IMPROVED, BUT THE LESION SLIGHTLY REMAINED." THE PATIENT DID NOT RETURN TO THE CLINIC, THE INFILTRATE WAS CONSIDERED TO BE RESOLVED. NO ADDITIONAL INFORMATION PROVIDED. PRODUCT WAS NOT RECEIVED. THIS IS BEING REPORTED AS A SERIOUS ADVERSE EVENT DUE TO THE REPORT OF AN INFECTIOUS CORNEAL INFILTRATE. A LOT HISTORY REVIEW WAS PERFORMED, THE RESULTS REVEALED THE FOLLOWING: THE BATCH RECORD DID NOT SHOW ANY ABNORMALITIES IN MONOMER AND SOLUTION TESTING. ALL PARAMETERS TESTED WERE WITHIN SPECIFICATION. ALL STERILIZATION REQUIREMENTS WERE SUCCESSFULLY COMPLETED. IF ADDITIONAL INFORMATION IS RECEIVED, WILL REPORT WITHIN 30 DAYS OF RECEIPT. MDR REPORTABLE EVENT TRENDS ARE REVIEWED QUARTERLY IN EXECUTIVE MANAGEMENT REVIEW MEETINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT PING METER GLUCOSE MONITORING SYS/KIT MDS LIFESCAN, INC. 2990683

    Patients

    Seq Age Sex Outcome Treatment
    1