BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 1823231 · Received September 2, 2010

    Report

    Report Number
    2939301-2010-07511
    Event Type
    Malfunction
    Date Received
    September 2, 2010
    Report Date
    August 30, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    MDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENT'S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED IN THIS CASE HAS PASSED TESTING WITH NO FAULTS FOUND. 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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), AN INCREASED RIGHT VENTRICULAR (RV) IMPEDANCE OF GREATER THAN 2000 OHMS, AND NOISE ON THE RV CHANNEL WERE OBSERVED. THE LEAD WAS REINSERTED INTO THE HEADER, AND THE PHYSICIAN NOTED A LOT OF 'BACK PRESSURE'. ON THE FOURTH ATTEMPT, MINERAL OIL WAS USED WITH SUCCESS. TO DATE, THERE HAVE BEEN NO REPORTED ADVERSE PATIENT EFFECTS RELATED TO THIS CLINICAL OBSERVATION.

    Description of Event or Problem · 1

    THE LAY USER/PATIENT CONTACTED LIFESCAN ALLEGING THE METER DOES NOT POWER ON. 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. 3023540

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR