BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PTS PANELS CREATININE TEST STRIPS

    MDR report key: 2557488 · Received May 2, 2012

    Report

    Report Number
    1836135-2012-00001
    Event Type
    Malfunction
    Date Received
    May 2, 2012
    Date of Event
    April 3, 2012
    Report Date
    April 23, 2011
    Manufacturer
    POLYMER TECHNOLOGY SYSTEMS
    Product Code
    JFY
    PMA / PMN Number
    K010456
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    AS PART OF A ROUTINE PRODUCT INVESTIGATION ((B)(4)), A PROGRAMMING ERROR WAS DISCOVERED WITH THE VERSION 2.60 CARDIOCHEK PA METER WHEN USED IN CONJUNCTION WITH CREATININE LOT F103. THE PROGRAMMING ERROR CREATED A POTENTIAL FOR AN ERRONEOUS RESULT DISPLAY FOR ANY VALUES LESS THAN 1.0 MG/DL. THIS ASSAY OF CREATININE ALONG WITH THE CARDIOCHEK IS THE ONLY ASSAY THAT WILL REPORT VALUES LESS THAN 1.0 MG/DL. THE LOT WAS RELEASED IN DECEMBER AND NO COMPLAINTS OF THIS NATURE HAVE BEEN LOGGED AGAINST THIS LOT. THE NORMAL CLINICAL RANGES ARE 0.6-1.2 MG/DL FOR ADULT MALES AND 0.5-1.1 MG/DL FOR ADULT FEMALES. AN ELEVATED CREATININE LEVEL THAT IS OUTSIDE THE NORMAL REFERENCE RANGE IS AN INDICATION OF KIDNEY DAMAGE AND/OR REDUCED KIDNEY FUNCTION AND WOULD REQUIRE IMMEDIATE FOLLOW-UP TESTING. THE PROGRAMMING ERROR ONLY EFFECTS CREATININE RESULTS LESS THAN 1.0 MG/DL AND WOULD NOT BE ASSOCIATED WITH THE ABOVE DESCRIBED CLINICAL USAGES BASED ON THE EFFECTED RANGE OF LESS THAN 1.0 MG/DL. AN ERRONEOUS RECOVERY OF CREATININE IN A RESULT LESS THAN 1.0 MG/DL IS A TOLERABLE TO MANAGEABLE RISK BASED ON THE DEGREE OF ERRONEOUS RECOVERY AND THE FREQUENCY OF OCCURRENCE IF THE ERRONEOUS RECOVERY WILL STILL REPORT THE RESULT AS A VALUE LESS THAN 1.0 MG/DL. IF AN ERRONEOUS RESULT WAS TO OCCUR IN A CREATININE RESULT LESS THAN 1.0 MG/DL, THE SEVERITY WOULD BE ESTIMATED AS A LOW RISK IF THE ERRONEOUS RECOVERY WILL STILL REPORT THE RESULT AS A VALUE LESS THAN 1.0 MG/DL. THE IDENTIFIED PROGRAMMING ERROR ONLY EFFECTS RESULTS LESS THAN 1.0 MG/DL AND ANY ERRONEOUS RESULT PRODUCED WILL REPORT AS A VALUE LESS THAN 1.0 MG/DL. THE FREQUENCY OF THE PRODUCT ERRONEOUS RECOVERY IS ESTIMATED AS LOW TO OCCASIONAL BECAUSE THE ERROR WILL ONLY OCCUR IN RESULTS LESS THAN 1.0 MG/DL. WE HAVE THUS UNDERTAKEN A FIELD CORRECTION FOR THIS LOT WHICH HAS ONLY BEEN DISTRIBUTED TO A VERY LIMITED NUMBER OF CUSTOMERS THROUGH TWO DISTRIBUTORS IN THE USA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PTS PANELS CREATININE TEST STRIPS CREATININE TEST STRIPS JFY POLYMER TECHNOLOGY SYSTEMS F103

    Patients

    Seq Age Sex Outcome Treatment
    1