BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 1901875 · Received November 17, 2010

    Report

    Report Number
    2939301-2010-10072
    Event Type
    Malfunction
    Date Received
    November 17, 2010
    Report Date
    November 3, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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 12/13/2010. 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.

    Description of Event or Problem · 1

    THERE IS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE CLOUDY WAS NOT RESOLVED WITH TROUBLESHOOTING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS LOW IMPEDANCE ON BOTH THE RIGHT VENTRICULAR (RV) AND ATRIAL LEADS. THE RV LEAD WAS CAPPED AND REPLACED, AND THE ATRIAL LEAD WAS REPROGRAMMED TO UNIPOLAR AND REMAINS IN USE. DURING THE ATTEMPT TO IMPLANT A NEW ATRIAL LEAD, THE PHYSICIAN WAS UNABLE TO GET THE SECOND INTRODUCER DOWN FOR THE ATRIAL LEAD. THE LEAD WAS NOT USED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3054219

    Patients

    Seq Age Sex Outcome Treatment
    1