BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DADE INNOVIN

    MDR report key: 6662787 · Received June 23, 2017

    Report

    Report Number
    9610806-2017-00065
    Event Type
    Malfunction
    Date Received
    June 23, 2017
    Date of Event
    June 1, 2017
    Report Date
    June 23, 2017
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
    Product Code
    GJS
    PMA / PMN Number
    K974343
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS HEALTHCARE DIAGNOSTICS INC. (SIEMENS) ANALYZED THE BCS XP SYSTEM BACK UP (DMT) FILES, ACCOUNT HISTORY AND DATA MAINTENANCE FILES TO DETERMINE THE CAUSE OF THE DISCORDANT, FALSELY ELEVATED PROTHROMBIN TIME (PT) INTERNATIONAL NORMALIZED RATIO (INR) RESULTS AND FOUND NO SYSTEMIC, REAGENT OR SOFTWARE ISSUES. VISUAL REVIEW OF THE KINETIC CURVES FOR THE PT 570 NM ASSAY AND THE PT 405 NM ASSAY INDICATED THAT THE SAMPLES POTENTIALLY HAD UNDERWENT UNACCEPTABLE HANDLING PRIOR TO ANALYSIS, EVEN THOUGH THE OPERATOR STATED THAT THEY DID NOT OBSERVE A PRE-ANALYTICAL SAMPLE CONDITION SUCH AS: HEMOLYSIS, LIPEMIA, OR ICTERUS. THE OPERATOR STATED THAT THEY CENTRIFUGE SAMPLES AT 7200 ROTATIONS PER MINUTE (RPM) FOR 2 MINUTES TO PREPARE COAGULATION SAMPLES, WHICH IS CONSISTENT WITH "STAT SPIN" PRACTICES. IT HAS BEEN DEMONSTRATED THAT WHILE PLATELET POOR PLASMA MAY BE INITIALLY PRODUCED WITH THIS PRACTICE, IF SAMPLES WERE TO SIT, WITHIN 10 MINUTES, PLATELETS CAN RE-SUSPEND. PLATELET RE-SUSPENSION IN THE PLASMA SAMPLES TESTED MAY HAVE POTENTIALLY CONTRIBUTED TO THE DISCORDANT RESULTS. THE INSTRUMENT AND THE REAGENTS ARE PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE OR REAGENTS IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT, FALSELY ELEVATED PROTHROMBIN TIME (PT) INTERNATIONAL NORMALIZED RATIO (INR) RESULTS WERE OBTAINED ON 3 PATIENT SAMPLES ON THE BCS XP SYSTEM ON (B)(6) 2017 USING THE DADE INNOVIN REAGENT. A DISCORDANT PT INR RESULT OF 4.1 INR WAS OBTAINED ON PRE-SURGICAL PATIENT SAMPLE ((B)(6)) ON THE BCS XP SYSTEM MEASURED ON THE PT 405NM ASSAY AT 6:48 AM. THIS RESULT WAS AUTOMATICALLY VERIFIED BY THE LABORATORY INFORMATICS SYSTEM (LIS) AND A PT INR RESULT OF 4.1 INR WAS REPORTED TO THE PHYSICIAN, WHO QUESTIONED THE RESULT. THE PATIENT BLOOD WAS RE-DRAWN AND RE-RUN ON THE SAME BCS XP SYSTEM MEASURED ON THE PT 405NM ASSAY AT 8:01 AM. A PT INR RESULT OF 1.0 INR WAS OBTAINED AND REPORTED TO THE PHYSICIAN. THE ORIGINAL PATIENT SAMPLE WAS ALSO RE-SPUN AND RE-RUN ON THE SAME BCS XP SYSTEM AND A RESULT OF 1.0 INR WAS OBTAINED. THIS PRE-SURGICAL PATIENT IS NOT ON ANTICOAGULATION MEDICATION. ANOTHER DISCORDANT FLAGGED PT INR RESULT OF 5.1 INR WAS OBTAINED ON ANOTHER PRE-SURGICAL PATIENT SAMPLE ((B)(6)) ON THE BCS XP SYSTEM MEASURED ON THE PT 405NM ASSAY AT 9:46 AM. THIS RESULT WAS FLAGGED WITH "MEASURING RANGE OF OPTICAL SYSTEM EXCEEDED". AS PER THE OPERATOR, ACCORDING TO THE FACILITY POLICY, THIS RESULT WAS CONSIDERED CRITICAL AND WAS SET FOR AUTOMATIC REFLEX ANALYSIS ON THE PT 570NM ASSAY AT 9:54 AM AND AN INR RESULT OF 1.4 INR WAS OBTAINED. THESE RESULTS (5.1 INR AND 1.4 INR) WERE NOT REPORTED TO THE PHYSICIAN. THE SAME PATIENT SAMPLE WAS RE-RUN ON THE SAME BCS XP SYSTEM ON THE PT 405 ASSAY AT 9:57 AM AND AN INR RESULT OF 1.3 INR WAS OBTAINED AND REPORTED TO THE PHYSICIAN. THIS PRE-SURGICAL PATIENT IS NOT ON ANTICOAGULATION MEDICATION. ANOTHER DISCORDANT PT INR RESULT OF 7.6 INR WAS OBTAINED ON A PATIENT SAMPLE ON THE BCS XP SYSTEM MEASURED ON THE PT 405 ASSAY AT 12:03 PM. AS PER THE OPERATOR, ACCORDING TO THE FACILITY POLICY, THIS RESULT WAS CONSIDERED CRITICAL AND WAS SET FOR AUTOMATIC REFLEX ANALYSIS ON THE PT 570NM ASSAY AND AN INR RESULT OF 3.1 INR WAS OBTAINED AT 12:11 PM. THESE RESULTS (7.6 INR AND 3.1 INR) WERE NOT REPORTED TO THE PHYSICIAN. THIS SAME PATIENT SAMPLE WAS RE-SPUN AND RE-RUN ON THE SAME BCS XP SYSTEM AND AN INR RESULT OF 2.9 INR WAS OBTAINED AT 12:43 PM ON THE PT 405NM ASSAY. THE INR RESULT OF 2.9 INR WAS REPORTED TO THE PHYSICIAN. IT IS UNKNOWN WHETHER THIS PATIENT WAS UNDER ANTICOAGULATION MEDICATION AND THE PATIENT WAS IN THE EMERGENCY ROOM. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, ELEVATED PT INR RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443936 DADE INNOVIN DADE INNOVIN GJS SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH DADE INNOVIN 539393

    Patients

    Seq Age Sex Outcome Treatment
    1