BEUDAMED
    FDA Adverse Event Other Summary report: N

    PTS PANELS CHOL+HDL+GLU TEST STRIPS

    MDR report key: 1412613 · Received July 7, 2009

    Report

    Report Number
    1836135-2009-00002
    Event Type
    Other
    Date Received
    July 7, 2009
    Date of Event
    May 20, 2009
    Report Date
    July 7, 2009
    Manufacturer
    POLYMER TECHNOLOGY SYSTEMS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K071507
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A COMPLAINT WAS RECEIVED FROM A DISTRIBUTOR IN (B)(4) REGARDING UNDER RECOVERY OF CHOLESTEROL AND HDL CHOLESTEROL USING PTS PANELS/CARDIOCHEK CHOL+HDL+GLU PANEL TEST STRIPS, LOT I891. AN INTERNAL INVESTIGATION OF THIS COMPLAINT CONFIRMED THE UNDER RECOVERY OF THESE ANALYTES FOR BOTH THE RETURNED (PREVIOUSLY OPENED) VIALS AND QC RETAINED VIALS FROM THE SAME LOT. THE UNDER RECOVERY OF CHOLESTEROL AND HDL CHOLESTEROL WAS EVIDENT TO A SIMILAR MAGNITUDE AS REPORTED BY THE CUSTOMER. BASED ON THE SIMILAR LOSS OF REACTIVITY OF BOTH THE RETURNED MATERIAL AND THE RETAINED MATERIAL, THIS LOT OF CHOL+HDL+GLU IS BEING RECOVERED FROM THE FIELD. FURTHER EVAL IS NOW UNDERWAY TO DETERMINE THE ROOT CAUSE AND EVALUATE ANY PERFORMANCE IMPACT ON THE RECOVERY OF THE GLUCOSE ANALYTES IN THIS PANEL. WE HAVE SUBMITTED THIS MEDICAL DEVICE REPORT TO ALERT USERS OF THIS LOT NUMBER OF PRODUCT WHILE THE EVAL CONTINUES AND THE FIELD NOTIFICATION COMMENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PTS PANELS CHOL+HDL+GLU TEST STRIPS GLUCOSE AND LIPOPROTEIN TEST SYSTEMS NBW POLYMER TECHNOLOGY SYSTEMS, INC. NA I891

    Patients

    Seq Age Sex Outcome Treatment
    1