BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 1850725 · Received October 1, 2010

    Report

    Report Number
    2939301-2010-08736
    Event Type
    Malfunction
    Date Received
    October 1, 2010
    Report Date
    September 24, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    MDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PATIENT

    Narratives

    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. THE METER WAS FOUND WITH BLACK MARKS ON 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.

    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

    ATTORNEY REPORTED: ON (B)(6)2007 - PT UNDERWENT VENTRAL HERNIA REPAIR SURGERY. PT'S HERNIA WAS REPAIRED WITH A SMALL OVAL BARD COMPOSIX KUGEL MESH. ON (B)(6)2009 - PT PRESENTED TO HOSPITAL SUFFERING FROM AN ENTEROCUTANEOUS FISTULA AND INFECTED MESH. PT IMMEDIATELY UNDERWENT SURGICAL REPAIR. DURING THE PROCEDURE, THE SURGEON NOTED THAT "THE SMALL BOWEL SEGMENT EXTENDED UP TO THE MESH AND WAS ADHERENT TO THE MESH." SURGEON DISSECTED THE SMALL BOWEL FROM THE MESH AND FOUND A SMALL OPENING IN THE SMALL BOWEL. SURGEON REPAIRED THE OPENING IN THE SMALL BOWEL BY PERFORMING A BOWEL RESECTION AND END-TO-END ANASTOMOSIS. ONCE THE SMALL BOWEL RESECTION HAD BEEN COMPLETED, THE OLD INFECTED MESH WAS EXCISED FROM THE ABDOMINAL WALL AND THE DEFECT WAS REPAIRED WITH AN ALLODERM MESH. ON (B)(6)2009 - PT WAS DISCHARGED. BECAUSE OF THE DEFECTIVE COMPOSIX KUGEL PATCH, AND THE MULTIPLE MEDICAL VISITS AND SURGERIES NECESSITATED, PT HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN AND MENTAL ANGUISH.

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT PING METER GLUCOSE MONITORING SYS/KIT MDS LIFESCAN, INC. 3043975

    Patients

    Seq Age Sex Outcome Treatment
    1