BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 1883681 · Received October 26, 2010

    Report

    Report Number
    2939301-2010-09500
    Event Type
    Malfunction
    Date Received
    October 26, 2010
    Report Date
    October 22, 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

    FOLLOW UP # 1/SUPPLEMENTAL REPORT TEXT-11/16/2010. 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.

    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

    REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(6) 2010. IT WAS REPORTED THAT DURING A CORONARY ARTERY STENTING TREATMENT PROCEDURE THERE WAS DIFFICULTY CROSSING THE LESION. THE LESION BEING TREATED WAS LOCATED IN THE CALCIFIED AND SEVERLY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY. PRE-DILATION WITH A MAVERICK BALLOON WAS PERFORMED AND THE 3.5X28MM PROMUS ELEMENT STENT DELIVERY SYSTEM WAS ADVANCED TO THE LESION. HOWEVER, THE DELIVERY SYSTEM COULD NOT CROSS THE LESION. ANOTHER MANUFACTURER'S 3.5X30MM STENT WAS ATTEMPTED, BUT ALSO COULD NOT CROSS THE LESION. ANOTHER PROMUS ELEMENT CROSSED THE LESION AND THE PROCEDURE WAS COMPLETED. THERE WERE NO REPORTED PATIENT COMPLICATIONS AND THE PATIENT STATUS WAS STABLE. HOWEVER, RETURNED PRODUCT ANALYSIS REVEALED STENT DAMAGE. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

    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 NBW LIFESCAN, INC. 3046585

    Patients

    Seq Age Sex Outcome Treatment
    1