BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STA COMPACT MAX PERCAGE

    MDR report key: 8408876 · Received March 11, 2019

    Report

    Report Number
    8043273-2019-00002
    Event Type
    Injury
    Date Received
    March 11, 2019
    Date of Event
    February 12, 2019
    Report Date
    April 12, 2019
    Manufacturer
    DIAGNOSTICA STAGO S.A.S.
    Product Code
    JPA
    PMA / PMN Number
    K130090
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PREVIOUS EVENT: THERE IS NO PREVIOUS EVENT RELATED TO THE ISSUE DESCRIBED IN THE INITIAL REPORT. INVESTIGATIONS / IDENTIFICATION OF CAUSES: AS WRITTEN IN THE CUSTOMER QUESTIONNAIRE, THE QUALITY CONTROLS BEFORE AND AFTER THE SAMPLE WERE WITHIN THE APPROPRIATE RANGES. AS INDICATED IN THE LOGS, THE SAME LOT OF REAGENTS WAS USED FOR BOTH TESTS IN DAY 1 AND DAY 2. THEREFORE, A DEFECT LINKED TO THE LOT OF THE REAGENTS IS UNLIKELY. THE RAW RESULT IN DELTA OD FOR THE D-DIMER TEST OF THE PATIENT IN DAY 1 WAS 0 WHICH RESULTED IN A D-DIMER CONCENTRATION OF 215NG/ML. AS WRITTEN IN THE PACKAGE INSERT, "THIS ASSAY IS BASED ON THE CHANGE IN TURBIDITY OF A MICROPARTICLE SUSPENSION THAT IS MEASURED BY PHOTOMETRY. A SUSPENSION OF LATEX MICROPARTICLES, COATED BY COVALENT BONDING WITH MONOCLONAL ANTIBODIES SPECIFIC FOR D-DIMER, IS MIXED WITH THE TEST PLASMA WHOSE D-DIMER LEVEL IS TO BE ASSAYED. AN ANTIGEN-ANTIBODY REACTION TAKES PLACE, LEADING TO AN AGGLUTINATION OF THE LATEX MICROPARTICLES WHICH INDUCES AN INCREASE IN TURBIDITY OF THE REACTION MEDIUM. THIS INCREASE IN TURBIDITY IS REFLECTED BY AN INCREASE IN ABSORBANCE, THE LATTER BEING MEASURED PHOTOMETRICALLY. THE INCREASE IN ABSORBANCE IS A FUNCTION OF THE D-DIMER LEVEL PRESENT IN THE TEST SAMPLE." THE STUDY OF THE LOGS SHOWS THAT THE KINETICS FOR THIS TEST ARE COMPLETELY FLAT WHICH MEANS THERE WAS NO REACTION ON THE MEDIUM. THE INVESTIGATIONS REVEAL THAT THERE WAS NO PROBLEM OF LLD (LIQUID LEVEL DETECTION) DETECTED BY THE ANALYZER ON THE TUBE OR THE REAGENTS DURING THE D-DIMER TEST IN DAY 1. THE SAMPLE COLLECTION HEIGHTS WERE CONSISTENT BETWEEN DAY 1 AND DAY 2. THEREFORE, IT IS NOT A COLLECTION PROBLEM RELATED TO THE SAMPLE. IT WAS DETERMINED ON THE LOGS THAT THE TEST WAS RUN RIGHT AFTER LOADING NEW REAGENTS VIALS. IT APPEARS THAT THE COLLECTING HEIGHTS IN BUFFER AND LATEX VIALS ARE INCONSISTENT IN DAY 1: FOR BOTH VIALS, THE NUMBER OF STEPS BETWEEN THE 1ST COLLECTION (CORRESPONDING TO OUR PATIENT'S TEST) AND THE 2ND (FOR ANOTHER PATIENT'S TEST) IS HIGHER THAN EXPECTED. MOST PROBABLE ROOT CAUSE: AS THE 1ST COLLECTION IN BUFFER AND LATEX VIALS WAS NOT CONSISTENT, THE NEEDLE MOST LIKELY ENCOUNTERED A BUBBLE AND THIS BUBBLE MUST HAVE BURST AFTER THE 1ST COLLECTION. THIS INCOMPLETE COLLECTION OF SAMPLE WAS NOT DETECTED BY THE ANALYZER BECAUSE THE NEEDLE ACTUALLY TOUCHED LIQUID AROUND THE BUBBLE, SO THE LLD CHECK WAS CORRECT. IN THE PACKAGE INSERT, IT IS CLEARLY INDICATED TO "MIX THE REAGENTS BY GENTLE SWIRLING OF THE VIALS WITHOUT CREATING ANY BUBBLES. THEN, PLACE A NEW STA® - MINI REDUCER (REF 00797) AND THE PERFORATED CAP ON EACH VIAL." CORRECTIVE ACTIONS PROPOSED / CARRIED OUT FOLLOWING THE ANALYSIS OF THE CAUSES: NO CORRECTIVE ACTION WILL BE PUT IN PLACE FOR THIS CASE BASED ON THE INVESTIGATION CARRIED OUT AND THE ISOLATED NATURE OF THE ISSUET. HOWEVER, THE CUSTOMER HAS BEEN REMINDED TO BE AWARE OF THE SIGNIFICANCE OF FOLLOWING THE INSTRUCTIONS ON THE PACKAGE INSERT (AND OTHER RELEVANT ASSOCIATED DOCUMENTS). SET UP A VISUAL CONTROL OF THE REAGENTS WHEN THE CUSTOMER PLACES THE STA MINI REDUCER IN EACH VIAL AND WHEN THE VIALS ARE LOADED IN THE ANALYZER (LACK OF BUBBLES). STAGO HAS CONCLUDED ITS INVESTIGATION INTO THIS MATTER.

    Additional Manufacturer Narrative · 0

    DIAGNOSTICA STAGO, INC. IS SUBMITTING THIS REPORT ON BEHALF OF DIAGNOSTICA STAGO S..A.S. GENNEVILLIERS (MANUFACTURER) UNDER EXEMPTION NUMBER E2012018. THE EVENT OCCURRED IN BELGIUM BUT THE DEVICE IS ALSO MARKETED IN THE USA. THE ANALYZER'S LOGS HAVE BEEN RETRIEVED, INVESTIGATIONS ARE STILL ON GOING UNDER CORPORATE COMPLAINT RC-19-0014. STAGO WILL PROVIDE A FOLLOW-UP REPORT(S) ONCE RELEVANT INFORMATION HAS BECOME AVAILABLE.

    Description of Event or Problem · 0

    A PATIENT SAMPLE YIELDED A RESULT OF 215NG/ML UTILIZING STA LIATEST DDI PLUS (PROD# 00662 - LOT# 254415) ON AN STA COMPACT MAX ANALYZER ON (B)(6) 2019. THE LABORATORY WAS THEN INFORMED THAT THE PATIENT HAD A THROMBOSIS: THE CLINICIAN CONTACTED THE LABORATORY BY PHONE ASKING IF THE RESULT WAS CORRECT SINCE THE PATIENT SHOWED CLEAR SYMPTOMS OF DVT. THIS WAS CONFIRMED BY THE RADIOLOGY DEPARTMENT. THE SAME TUBE WAS RETESTED THE NEXT DAY AND YIELDED A RESULT OF >4000NG/ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201450 STA COMPACT MAX PERCAGE IVD COAGULATION DEVICE/INSTRUMENT JPA DIAGNOSTICA STAGO S.A.S.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other