BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PTS PANELS CHOL+GLU TEST STRIPS

    MDR report key: 1557244 · Received November 23, 2009

    Report

    Report Number
    1836135-2009-00003
    Event Type
    Malfunction
    Date Received
    November 23, 2009
    Date of Event
    October 14, 2009
    Report Date
    November 13, 2009
    Manufacturer
    POLYMER TECHNOLOGY SYSTEMS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K041750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER EVALUATION CONTINUES TO DETERMINE THE ROOT CAUSE OF THIS ACTIVITY LOSS. WE ARE SUBMITTING THIS MEDICAL DEVICE REPORT TO ALERT USERS OF THIS LOT NUMBER OF PRODUCT WHILE THE EVALUATION CONTINUES AND THE FIELD NOTIFICATION COMMENCES.

    Description of Event or Problem · 1

    AN INITIAL COMPLAINT WAS RECEIVED IN LATE (B)(6) FROM (B)(4), THE DISTRIBUTOR OF PTS PRODUCTS IN (B)(6). THEY REPORTED AN ERRATIC AND GENERAL UNDER-RECOVERY OF CHOLESTEROL AND GLUCOSE USING PTS PANELS/CARDIOCHEK CHOL +GLU PANEL TEST STRIP, LOT A8A2. THE INITIAL INTERNAL INVESTIGATION OF THIS COMPLAINT USING THE CUSTOMER'S OPENED RETURN MATERIAL SHOWED NOMINAL CHOLESTEROL RECOVERY AND A SLIGHT UNDER RECOVERY OF GLUCOSE WHICH WAS NOT CLINICALLY SIGNIFICANT. IT WAS DETERMINED THAT THE PRUDENT COURSE OF ACTION WAS TO RE-CONDUCT THE ANALYSIS OF THE LOT AFTER A FURTHER PERIOD OF PRODUCT "AGING" AND ACTIVE PRODUCT SURVEILLANCE. AFTER AN ADD'L MONTH, NO FURTHER COMPLAINTS WERE RECEIVED AND A SECOND PERFORMANCE EVALUATION WAS UNDERTAKEN IN MID-(B)(6). IN THIS STUDY, USING A CLINICAL APPLICATIONS EVALUATION PROTOCOL, THERE WAS NO APPRECIABLE LOSS OF CHOLESTEROL AND A MINOR LOSS OF GLUCOSE ACTIVITY. USING A HEALTH RISK ASSESSMENT IT WAS DETERMINED THAT THIS MARGINAL LOSS OF ACTIVITY DID NOT REPRESENT A HEALTH RISK, HOWEVER, PTS HAS ELECTED TO VOLUNTARILY CONDUCT A FIELD RECOVERY FOR LOT A8A2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PTS PANELS CHOL+GLU TEST STRIPS GLUCOSE AND LIPOPROTEIN TEST SYSTEMS NBW POLYMER TECHNOLOGY SYSTEMS, INC. NA A8A2

    Patients

    Seq Age Sex Outcome Treatment
    1 NA