BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 1792219 · Received August 10, 2010

    Report

    Report Number
    2939301-2010-06456
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Report Date
    July 19, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    MDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENT'S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED IN THIS CASE HAS PASSED TESTING WITH NO FAULTS FOUND. 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

    NOTE: THIS REPORT PERTAINS TO ONE OF FOUR DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2010-03859, 3005099803-2010-03860, AND 3005099803-2010-03861 ADDRESS THE OTHER DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RF 3000 RADIOFREQUENCY GENERATOR, A LEVEEN COACCESS ELECTRODE SYSTEM AND TWO SOLOIST SINGLE NEEDLE ELECTRODES WERE USED DURING A BONE RFA (RADIOFREQUENCY ABLATION) PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, AFTER PLACING THE PATIENT UNDER GENERAL ANESTHESIA, A SOLOIST ELECTRODE WAS ADVANCED TO THE TARGET REGION. HOWEVER, WHILE ATTEMPTING TO ABLATE, A CONSOLE ERROR (E02) OCCURRED. THE ELECTRODE WAS REMOVED FROM THE PATIENT AND A SECOND SOLOIST ELECTRODE WAS ADVANCED TO THE TARGET AREA, HOWEVER, A SECOND ERROR (E02) OCCURRED. THE ELECTRODE WAS REPOSITIONED DEEPER INTO THE BONE AND SALINE WAS APPLIED TO THE SITE, BUT THE ERROR REOCCURRED. THE SECOND SOLOIST ELECTRODE WAS REMOVED FROM THE PATIENT AND A LEVEEN COACCESS ELECTRODE WAS POSITIONED AND PARTIALLY DEPLOYED INTO THE LESION. THE PHYSICIAN HAD SOME SUCCESS, BUT ROLL-OFF WAS NOT ABLE TO BE ACHIEVED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    THE LAY USER/PATIENT CONTACTED LIFESCAN ALLEGING THE METER POWERS OFF DURING USE. 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. 3010690

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR