BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 1780062 · Received August 2, 2010

    Report

    Report Number
    2939301-2010-06144
    Event Type
    Malfunction
    Date Received
    August 2, 2010
    Report Date
    July 12, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    MDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    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 BATTERY CONTACT CORRODED. 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.

    Description of Event or Problem · 1

    WHEN THE FIRST COIL ((B)(4)) WAS ADVANCED IN THE (MC) MICROCATHETER (DETAIL UNKNOWN), FRICTION OCCURRED BETWEEN THE COIL AND THE MICROCATHETER DURING DELIVERY, HOWEVER, NO ADDITIONAL FORCE WAS UTILIZED TO ADVANCE OR REMOVE THE COIL/DELIVERY SYSTEM. THE DELIVERY SYSTEM WAS PULLED BACK AND THE COIL BECAME STRETCHED (UNRAVELED). THE COIL WAS REMOVED SUCCESSFULLY AND CHANGED TO OTHER NEW COIL (DETAIL UNKNOWN). THE SECOND COIL WAS ADVANCED IN THE MC WITHOUT ANY DIFFICULTY. THE PROCEDURE WAS COMPLETED USING OTHER COILS WITHOUT ANY PATIENT INJURY. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE (MC) MICROCATHETER AT ALL TIMES. AFTER THE DELIVERY SYSTEM WAS LOADED INTO THE MICROCATHETER, THE Y-CONNECTOR WAS LOCKED TO SECURE THE DELIVERY SYSTEM, AND NO DAMAGES WERE NOTICED ON THE DELIVERY SYSTEM AFTER THE Y CONNECTOR WAS CLOSED. OTHER THAN THE REPORTED EVENT, NO OTHER DAMAGES WERE NOTICED WITH ANY OTHER SECTION OF THE DEVICE, AND THE COIL WAS STILL ATTACHED TO THE DELIVERY SYSTEM. ACCESS SITE WAS FEMORAL ARTERY. THE TARGET SITE WAS THE DISTAL (AC) DISTAL ANTERIOR CEREBRAL ARTERY. NO OTHER INFORMATION WAS PROVIDED.

    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. 3020285

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR