BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 1901871 · Received November 17, 2010

    Report

    Report Number
    2939301-2010-10069
    Event Type
    Malfunction
    Date Received
    November 17, 2010
    Report Date
    November 3, 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 PCB CONTAMINATION. 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

    THERE IS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE METER REVERTING TO SETUP MODE WAS NOT RESOLVED WITH TROUBLESHOOTING.

    Description of Event or Problem · 1

    THE PATIENT HAD TWO LESIONS TREATED DURING THE INDEX PROCEDURE. A 2.5 MM DIAMETER X 24 MM LENGTH ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG-ELUTING STENT WAS IMPLANTED TO THE PROXIMAL LAD (REF MFR # 2953200-2010-02429). A 3.0 MM DIAMETER X 12 MM LENGTH ENDEAVOR SPRINT RX STENT WAS IMPLANTED TO THE DISTAL LAD ( REF MFR # 2953200-2010-02430). THE PATIENT IS REPORTED TO HAVE SUFFERED A SUSPECTED NON-Q-WAVE MI ONE DAY POST INDEX PROCEDURE. THE INFARCTION LOCATION WAS IDENTIFIED IN THE TERRITORY OF THE TARGET VESSEL. THE EVENT WAS TRIGGERED BY ELEVATED POST PROCEDURAL CARDIAC ENZYMES. PATIENT WAS ASYMPTOMATIC/FREE OF SYMPTOMS AT 1 MONTH, SIX MONTH, 1 YEAR AND 1.5 YEAR FOLLOW-UP. NO OTHER CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3027685

    Patients

    Seq Age Sex Outcome Treatment
    1