BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECIMEN GATE SCREENING CENTER

    MDR report key: 5059457 · Received September 6, 2015

    Report

    Report Number
    8043909-2015-00008
    Event Type
    Malfunction
    Date Received
    September 6, 2015
    Date of Event
    November 12, 2014
    Report Date
    September 6, 2015
    Manufacturer
    WALLAC OY, SUBSIDIARY OF PERKINELMER
    Product Code
    JQP
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    R2015006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE (B)(6) STATE PUBLIC HEALTH NEWBORN SCREENING LABORATORY USES THE PERKINELMER SCREENING CENTER MODULE OF SPECIMEN GATE (SGSC) SOFTWARE (A CLASS I MEDICAL DEVICE) TO STORE, RETRIEVE, AND PROCESS THE DATA ASSOCIATED WITH SPECIMEN TESTING INCLUDING BUT NOT LIMITED TO PATIENT DEMOGRAPHICS, TESTS ORDERED, TEST RESULTS, TEST RESULT INTERPRETATION, QUALITY CONTROL RESULTS, AND RESULT CODES (FLAGS) THAT MAY BE ASSOCIATED WITH THE SPECIMEN FROM ITS ENTRY INTO THE LABORATORY WORKFLOW UNTIL PATIENT REPORT IS GENERATED AND RELEASED. WHEN SGSC SOFTWARE IS INSTALLED, CONFIGURABLE SETTINGS ARE PROGRAMMED BASED ON THE CUSTOMER PREFERENCES. FOR INSTANCE, EACH LABORATORY ENTERS THEIR SPECIFIC POPULATION BASED REFERENCE RANGES THAT ARE USED TO EVALUATE IF A PATIENT'S TEST RESULTS ARE NORMAL, BELOW OR ABOVE THE REFERENCE RANGE AND REQUIRE FURTHER ACTION SUCH AS REPEAT TESTING. THIS LABORATORY SPECIFIC LOGIC AUTOMATES THE FLOW OF THE SPECIMEN THROUGH THE LABORATORY. THE CUSTOMER DEFINES THE NOMENCLATURE USED FOR THEIR RESULT CODES (FLAGS), AND WHEN THE SOFTWARE ENCOUNTERS THE PREDEFINED RESULT CODE THE SOFTWARE PROCESSES THE SPECIMEN ACCORDING TO THE LOGIC ASSOCIATED WITH THE RESULT CODE. OCCASIONALLY THE LABORATORY RECEIVES SPECIMENS FROM ADULTS TO BE TESTED FOR PKU TREATMENT MONITORING. THE NEWBORN SCREENING LABORATORY RECEIVED 5 SPECIMENS FOR THE PATIENT. THE FIRST SPECIMEN WAS RECEIVED ON (B)(6) 2014. THE SPECIMEN WAS DENOTED AS A PKU DIETARY MONITORING SPECIMEN BASED ON LABORATORY PROTOCOL. THE SPECIMEN WAS ONLY ANALYZED FOR MSMS DISORDERS AND THE REPORT WAS PRINTED ON (B)(6) 2014 AT 10:11 AM. THE SECOND SPECIMEN WAS RECEIVED ON (B)(6) 2014. THE INITIAL HGB ANALYTE WAS ABNORMAL (AF PATTERN) TRIGGERING A CONFIRMATION REQUEST. THE LABORATORY CANCELLED THE CONFIRMATION REQUEST ON (B)(6) 2014 AT 2:24 PM. THE LABORATORY TECH THEN UPDATED THE RESULT CODE OF THE INITIAL HGB ANALYTE TEST TO A CONFIRMATION RESULT CODE, BUT DID NOT UPDATE THE DISORDER, HAVING IT REMAIN AS AN INITIAL TO BE CONFIRMED RESULT. THE REPORT WAS PRINTED ON (B)(6) 2014 AT 2:54 PM SHOWING HGB DISORDER AS NORMAL, EVEN THOUGH THE TEST NEEDED TO BE CONFIRMED. THE THIRD SPECIMEN WAS RECEIVED ON (B)(6) 2014. THE SPECIMEN WAS DENOTED AS A PKU DIETARY MONITORING SPECIMEN BASED ON LABORATORY PROTOCOL. THE SPECIMEN WAS ONLY ANALYZED MSMS DISORDERS AND THE REPORT WAS PRINTED ON (B)(6) 2014 AT 10:22 AM. THE LABORATORY DID PRINT, EDIT, AND FAX THE REPORT ON (B)(6) 2014. THE FOURTH SPECIMEN WAS RECEIVED ON (B)(6) 2015. THE SPECIMEN WAS DENOTED AS A PKU DIETARY MONITORING SPECIMEN BASED ON LABORATORY PROTOCOL. THE SPECIMEN WAS ONLY ANALYZED MSMS DISORDERS AND THE REPORT WAS PRINTED ON (B)(6) 2015 AT 10:25 AM. THE FIFTH SPECIMEN WAS RECEIVED ON (B)(6) 2015. THE SPECIMEN WAS DENOTED AS A PKU DIETARY MONITORING SPECIMEN BASED ON LABORATORY PROTOCOL. THE SPECIMEN WAS ONLY ANALYZED MSMS DISORDERS AND THE REPORT WAS PRINTED ON (B)(6) 2015 AT 8:41 AM. THE PATIENT REPORT RELEASED DID NOT CONTAIN ANY ERRONEOUS CONTENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590673 SPECIMEN GATE SCREENING CENTER DATA PROCESSING SOFTWARE JQP WALLAC OY, SUBSIDIARY OF PERKINELMER VERSION 1.6 NONE

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR