BEUDAMED
    FDA Adverse Event Other Summary report: N

    SPECIMEN GATE LABORATORY

    MDR report key: 2418302 · Received January 9, 2012

    Report

    Report Number
    8043909-2011-00002
    Event Type
    Other
    Date Received
    January 9, 2012
    Date of Event
    September 30, 2011
    Report Date
    January 4, 2012
    Manufacturer
    PERKINELMER, WALLAC OY
    Product Code
    JQP
    PMA / PMN Number
    B23026
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INVESTIGATION MADE THROUGH REMOTE CONNECTION, THERE WAS NO DEFECT IN THE DEVICE (SPECIMEN GATE LABORATORY), BUT THE CUT-OFF'S GIVEN FOR BIOT AND GALT ASSAYS WERE CHANGED WITHOUT PROPER CHANGE CONTROL AFTER THE GO-LIVE DATE. THE ACTUAL INSTRUMENT (ASTORIA SPOTCHECK PRO) AND THE KITS USED FOR THE ASSAYS ARE NOT MANUFACTURED BY PERKINELMER, AND THEREBY PKI IS NOT CAPABLE OF ASSESSING THE PERFORMANCE OF THE ASSAY OR THE VALIDITY OF THE CUT-OFF'S APPLIED.

    Description of Event or Problem · 1

    A GALT ASSAY OF A NEWBORN WAS REPORTED AS A NORMAL RESULT ON (B)(6) 2011 BY (B)(6). IN THE WEEKS FOLLOWING BIRTH, THE NEWBORN WAS ADMITTED TO THE HOSPITAL BECAUSE OF FAILURE TO THRIVE AND CATARACTS. THE PATIENT WAS CLINICALLY DIAGNOSED POSITIVE FOR GALACTOSEMIA AND HAD BEEN IN THE ICU FOR AT LEAST ONE MONTH AT THE TIME THE INCIDENT WAS REPORTED TO PKI. (B)(6) LAB PERSONNEL DID NOT NOTIFY PERKINELMER UNTIL (B)(4) 2011. THE INCIDENT TOOK PLACE SHORTLY AFTER THE (B)(6) DATA MANAGEMENT SYSTEM - (B)(6) - WAS CONFIGURED FOR COLLECTION OF DATA FROM A NEW ASTORIA SPOTCHECK PRO INSTRUMENT, WHICH WAS TO BE USED TO RUN BOTH BIOT (BIOTINIDASE) AND GALT (GALACTOSEMIA) ASSAYS. A CHANGE REQUEST ((B)(4)) WAS ISSUED TO PERKINELMER, AS MANUFACTURER AND DISTRIBUTOR OF THE SPECIMEN GATE LABORATORY DEVICE, TO PERFORM THE CONFIGURATION. ON GO-LIVE DATE (09/21/2011), THE CUT-OFF'S FOR BOTH ANALYTES WERE UPDATED TO BE AS SPECIFIED BY (B)(6). REGARDING GALT, THE DEFINED CUT-OFF VALUES AS CAPTURED IN THE AUDIT TRAIL WHERE: >1.2 FOR THE INITIAL GALT DETERMINATION AS NORMAL. >1 FOR THE CONFIRMATION GALT DETERMINATION AS NORMAL. ASSAY VALUES < = 1.2 OR < -1 WOULD BE CONSIDERED TO INDICATE AN ELEVATED RISK FOR GALACTOSEMIA. ON (B)(6) 2011, THE AUDIT TRAIL CAPTURED THAT NEW CUT-OFFS FOR BIOT AND GALT WERE ACTIVATED AT 9:32 AM. FOR BOTH ANALYTES, THE 'EQUAL TO' OPERATOR (-) WAS ADDED TO BOTH THE INITIAL AND THE CONFIRMATION LOGIC. AS A RESULT OF THIS CHANGE, THE APPLIED CUT-OFF VALUES FOR GALT WERE: > = 1.2 FOR THE INITIAL GALT DETERMINATION AS NORMAL. > = 1 FOR THE CONFIRMATION GALT DETERMINATION AS NORMAL. ASSAY VALUES LOWER THAN 1.2 OR 1 WOULD BE CONSIDERED TO INDICATE AN ELEVATED RISK FOR GALACTOSEMIA. AS A CONSEQUENCE, THE PATIENT RESULT 1.2 FOR ASSAY #112730006 WAS FLAGGED AS "NORMAL", AND NO CONFIRMATORY TEST WAS ORDERED. ON (B)(4) 2011, THE ORIGINAL CUT-OFF OPERATORS FOR GALT (WITHOUT 'EQUAL TO') WERE RE-CONFIGURED. BASED ON A REQUEST BY (B)(6), THE INITIAL AND CONFIRMATION CUT-OFF VALUES FOR GALT WERE FURTHER ADJUSTED FROM 1.2 AND 1.0 TO 3.2 AND 2.0 RESPECTIVELY, TO FIT THE ASTORIA SPOTCHECK PRO INSTRUMENT/METHOD. THE CHANGE WAS IMPLEMENTED ON (B)(4) 2011 AS FOLLOWS: >3.2 FOR THE INITIAL GALT DETERMINATION AS NORMAL. >2 FOR THE CONFIRMATION GALT DETERMINATION AS NORMAL. CONCENTRATIONS AND RESULT CODES FOR BOTH BIOT AND GALT WERE REVIEWED FROM (B)(4) 2011 THROUGH (B)(4) 2011 TO DETERMINE IF ANY OTHER CASES WERE FALSELY FLAGGED. NO OTHER CASES WERE IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECIMEN GATE LABORATORY JQP PERKINELMER, WALLAC OY 5002-0180 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention