BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 1843201 · Received September 23, 2010

    Report

    Report Number
    2939301-2010-08371
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Report Date
    September 14, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    MDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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'S DISPLAY WAS FOUND TO BE CRACKED/BROKEN. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A 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

    IT WAS REPORTED THAT POST OP OF A CORONARY ARTERY BYPASS GRAFT PROCEDURE WHEN THE SURGEON HARVESTED THE SAVENOUS VEIN, THE DEVICE JAMMED AND HE COULD NOT FIRE THE DEVICE. HE USED A SECOND CLIP APPLIER TO CONTINUE THE PROCEDURE. THE PATIENT HAD BEEN IN RECOVERY FOR 4-5 HOURS WHEN THE ATTENDING NURSE NOTICED EXCESSIVE BLOOD IN THE DRAIN; THE SURGEON DECIDED TO RETURN THE PATIENT TO THE OPERATING ROOM AND PERFORM AN ADDITIONAL SURGERY. WHEN HE OBSERVED THE VEIN SITE THERE WAS A MISSING CLIP AND THE CLIP LINE WAS LEAKING. THE SURGEON THEN SUTURED OVER THE CLIP LINE TO STOP THE LEAK. THE PATIENT REQUIRED 2 UNITS OF BLOOD AND ADDITIONAL TIME IN ICU. PATIENT HAS NOW BEEN RELEASED HOME AT THIS TIME. DEVICE WAS DISCARDED AT THE ACCOUNT EARLIER THAT DAY.

    Description of Event or Problem · 1

    THE LAY USER/PATIENT CONTACTED LIFESCAN ALLEGING THE METER HAS A DAMAGED 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 MDS LIFESCAN, INC. 3025055

    Patients

    Seq Age Sex Outcome Treatment
    1