BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 1834344 · Received September 14, 2010

    Report

    Report Number
    2939301-2010-07936
    Event Type
    Malfunction
    Date Received
    September 14, 2010
    Report Date
    September 3, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    MDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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; 510 (K) # IS K082590.

    Additional Manufacturer Narrative · 1

    FOLLOW UP # 1/SUPPLEMENTAL REPORT TEXT-12/01/2010. 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 PCB CONTAMINATION. A SECONDARY ISSUE WAS ALSO NOTED AS BATTERY LEAKAGE. 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

    THE LAY USER/PATIENT CONTACTED LIFESCAN ALLEGING THE METER DISPLAYS AN ERROR 1 MESSAGE WHEN A STRIP IS INSERTED OR A BUTTON IS PRESSED. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WERE NO ALLEGATIONS OF HARM OR INJURY. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT.

    Description of Event or Problem · 1

    SAME CASE AS MFR#: 2134265-2010-04126. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, THE BALLOON CATHETER BECAME STUCK ON THE GUIDE WIRE. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE 182CM CHOICE FLOPPY GUIDE WIRE WAS PLACED IN THE LESION AND A 2.5MM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. WHILE EXCHANGING THE 2.5MM MAVERICK BALLOON CATHETER FOR A DIFFERENT SIZE MAVERICK, THE SECOND MAVERICK BECAME STUCK ON THE GUIDE WIRE. THE PHYSICIAN PULLED ON THE GUIDE WIRE AND IT DETACHED, LEAVING A PORTION OF THE GUIDE WIRE IN THE LUMEN OF THE BALLOON CATHETER. THE MAVERICK BALLOON CATHETER AND THE REMAINING PORTION OF THE CHOICE FLOPPY GUIDE WIRE WERE REMOVED TOGETHER AS A UNIT. THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICES. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT PING METER GLUCOSE MONITORING SYS/KIT MDS LIFESCAN, INC. 2879435

    Patients

    Seq Age Sex Outcome Treatment
    1