BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 1802192 · Received August 17, 2010

    Report

    Report Number
    2939301-2010-06624
    Event Type
    Malfunction
    Date Received
    August 17, 2010
    Report Date
    July 26, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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. 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 DISPLAY IS FADING. 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 REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN 80CM TWO PORT THROUGH THE PEG JEJUNAL FEEDING TUBE (J-TUBE) WAS BEING USED FOR THE PURPOSE OF ADMINISTERING MEDICATION FOR ADVANCED STAGE PARKINSON'S DISEASE. THE PLACEMENT PROCEDURE WAS PERFORMED ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, POST PROCEDURE ON (B)(6) 2010, THE PATIENT PRESENTED WITH ABDOMINAL PAIN AND A GASTRIC ULCER. THE PHYSICIAN PERFORMED A DIAGNOSTIC GASTROSCOPY. ON (B)(6) 2010, THE PHYSICIAN REMOVED THE J-TUBE FROM THE PATIENT. THE PATIENT RECEIVED NO MEDICATION FOR TREATMENT OF THE GASTRIC ULCER. AFTER THE PATIENT'S GASTRIC ULCER RECOVERED, THE PHYSICIAN PLACED A NEW 80CM TWO PORT THROUGH THE PEG JEJUNAL FEEDING TUBE (J-TUBE) ON (B)(6) 2010. THE PATIENT'S CONDITION WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. 3027238

    Patients

    Seq Age Sex Outcome Treatment
    1