BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 1792093 · Received August 10, 2010

    Report

    Report Number
    2939301-2010-06405
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Report Date
    July 16, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    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

    ADDENDUM 08/18/2010: THE PATIENT'S PROCEDURAL SUMMARY SHOWED THAT THE PATIENT UNDERWENT PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY DISTAL TO THE RCA/PDA WITH A NON-CORDIS BALLOON DURING THE INDEX PROCEDURE. APPROXIMATELY TWO MONTHS POST INDEX PROCEDURE, THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH CARDIAC CHEST PAIN AND WAS ADMITTED THE FOLLOWING DAY. A PERCUTANEOUS CORONARY INTERVENTION (PCI) OF THE DISTAL RCA/PDA WITH A DES WAS PERFORMED ON (B)(6) 2010. THE RCA/PDA HAD 80% DISTAL STENOSIS. THE LESION WAS TREATED WITH A CYPHER STENT. POST PROCEDURE STENOSIS WAS 0%. ANGIOGRAPHY SHOWED THAT THE STENTS IMPLANTED IN THE LAD IN 2009 AND THE CYPHER IMPLANTED IN (B)(6) 2010 WERE PATENT.

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. 3024667

    Patients

    Seq Age Sex Outcome Treatment
    1