BEUDAMED
    FDA Adverse Event Summary report: N

    PTS PANELS GLUCOSE TEST STRIPS

    MDR report key: 3049323 · Received April 9, 2013

    Report

    Report Number
    1836135-2013-00001
    Date Received
    April 9, 2013
    Date of Event
    March 8, 2013
    Report Date
    April 4, 2013
    Manufacturer
    POLYMER TECHNOLOGY SYSTEMS
    Product Code
    CGA
    PMA / PMN Number
    010368
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE COMPLAINT WAS RECEIVED FROM (B)(6), WHERE THEY REPORTED UNDER-RECOVERY OF GLUCOSE LOT NUMBER U117 (EXP: 2013 05 08). THE CUSTOMER REPORTED COMPARATIVE DATA BETWEEN GLUCOSE TEST STRIPS LOT NUMBERS U117 AND U204 GLUCOSE RESULTS USING A CARDIOCHEK PA (CCPA). A TOTAL OF THREE TESTS WERE PERFORMED BY THE CUSTOMER WITH GLUCOSE LOT NUMBER U117 STRIPS AND ALL TESTS DEMONSTRATED LOWER THAN EXPECTED RESULTS. A TOTAL OF TWO TESTS WERE PERFORMED BY THE CUSTOMER WITH GLUCOSE LOT NUMBER U204 STRIPS AND ALL RESULTS WERE WITHIN THE ACCEPTABLE LIMITS. THE CUSTOMER RETURNED PRODUCT HAD NOT YET BEEN RETURNED AT THE TIME THIS PIR WAS WRITTEN. UNDER-RECOVERY WAS VERIFIED IN THE QC RETAINED STRIPS FOR GLUCOSE LOT NUMBER U117.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147998 PTS PANELS GLUCOSE TEST STRIPS NONE CGA POLYMER TECHNOLOGY SYSTEMS U117

    Patients

    Seq Age Sex Outcome Treatment
    1