BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LA 1 SCREENING REAGENT

    MDR report key: 7339667 · Received March 14, 2018

    Report

    Report Number
    9610806-2018-00033
    Event Type
    Malfunction
    Date Received
    March 14, 2018
    Date of Event
    February 13, 2018
    Report Date
    March 14, 2018
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
    Product Code
    GIR
    UDI-DI
    00842768007477
    PMA / PMN Number
    K922326
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED SIEMENS AND REPORTED THAT THEY OBTAINED A DISCORDANT, FALSELY ELEVATED LUPUS ANTICOAGULANTS (LA) 1 SCREENING REAGENT CLOTTING TIME PATIENT RESULT ON A BCS XP SYSTEM USING THE LA 1 SCREENING REAGENT. THE CUSTOMER REPORTED THAT THEY RECEIVE FROZEN SAMPLES. UPON RECEIPT, THE CUSTOMER THAWS THE SAMPLES IN A 37 DEGREES WATER BATH FOR 5-10 MINUTES PRIOR TO PLACING IT ON A ROCKER. THE SAMPLE IS THEN ROCKED FOR 5-20 MINUTES. THE CUSTOMER ALSO REPORTED THAT THEY CONDUCT A MEDICAL REVIEW OF ABNORMAL RESULTS BY COMPARING THE ABNORMAL RESULT TO RESULTS OBTAINED ON OTHER PARAMETERS FOR THE PATIENT. A SIEMENS HEADQUARTERS SUPPORT CENTER (HSC) SPECIALIST CONTACTED THE CUSTOMER TO INVESTIGATE THE CAUSE OF THE EVENT AND DETERMINED THAT PREVENTIVE MAINTENANCE (PM) IS PERFORMED AS REQUIRED AND UP TO DATE FOR BOTH SYSTEMS. THE CUSTOMER REPORTED THAT THEIR LAB HAS 4 BCS XP SYSTEMS AND INDEPENDENT REAGENT VIALS ARE LOADED INTO EACH SYSTEM. A DISCORDANT RESULT WAS OBTAINED ON A SPECIFIC SAMPLE ALIQUOT, WHICH POTENTIALLY CONTAINED SMALL BUBBLES OR FOAM THAT MAY HAVE LED TO INADEQUATE SAMPLE ASPIRATION. THE HSC SPECIALIST DETERMINED THAT INADEQUATE SAMPLE ASPIRATION AND THE USE OF DIFFERENT REAGENT VIALS AND SYSTEMS, UTILIZED TO TEST THE SAME SAMPLE, POTENTIALLY CONTRIBUTED TO THE DIFFERENT RESULTS OBTAINED ON THE PATIENT SAMPLE. THE SAMPLE WAS REPEATED WITHIN 2.5 HOURS AND WHILE THE CUSTOMER HAS VALIDATED THE STABILITY OF 8 HOURS FOR THAWED SAMPLES FOR LA ASSAYS, THIS HAS NOT BEEN CONFIRMED BY SIEMENS. THE HSC SPECIALIST DETERMINED THAT THE RESULTS FROM THE OTHER SCREENING TESTS (APTT AND FACTOR VIII) GENERALLY REFLECTS THAT THE PATIENT WAS NOT UNDER ANTICOAGULANTS. THE HSC SPECIALIST DETERMINED THERE IS NO INDICATION OF A SYSTEM MALFUNCTION, MEDICATION INTERFERENCE OR POOR BLOOD COLLECTION PROCESS. THE HSC SPECIALIST ALSO DETERMINED THAT THE CUSTOMER USED SIEMENS APPLICATION AS BASE ASSAYS. A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE FOR ROTOR HANDLER AND RACK TRANSFER ERRORS ON 15-FEB-2018. THE HSC SPECIALIST DETERMINED THAT THIS SERVICE WAS UNRELATED TO THIS EVENT. THE CAUSE OF THE EVENT IS UNKNOWN. THE SYSTEMS AND REAGENT ARE PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THESE SYSTEMS AND REAGENT IS REQUIRED. MDR 9610806-2018-00032 AND MDR 9610806-2018-00034 WERE FILED FOR THE SAME EVENT.

    Description of Event or Problem · 1

    A DISCORDANT, FALSELY ELEVATED LUPUS ANTICOAGULANTS (LA) 1 SCREENING REAGENT CLOTTING TIME RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A BCS XP SYSTEM USING THE LA 1 SCREENING REAGENT. DUE TO THE ELEVATED RESULT, THE SAMPLE WAS TESTED FOR LA 2 CONFIRMATION REAGENT CLOTTING TIME AND A RATIO WAS CALCULATED FROM THESE RESULTS. BASED ON THE LAB'S RANGES, THE RATIO SIGNIFIED THAT THE PATIENT WAS POSITIVE FOR LA. NONE OF THESE RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS RERUN ON AN ALTERNATE BCS XP SYSTEM, RESULTING IN A LOWER LA 1 SCREENING REAGENT CLOTTING TIME RESULT. THE SAMPLE WAS ALSO TESTED FOR LA 2 CONFIRMATION REAGENT CLOTTING TIME AND A RATIO WAS CALCULATED FROM THESE RESULTS. THE RATIO SIGNIFIED THAT THE PATIENT WAS WEAKLY POSITIVE FOR LA. SINCE THE PATIENT'S ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) AND FACTOR VIII RESULTS RECOVERED WITHIN NORMAL RANGES, A LA RATIO OF 1.3 WAS REPORTED TO THE PHYSICIAN(S), WHO DID NOT QUESTION THE RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED LA 1 SCREENING REAGENT CLOTTING TIME RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180177 LA 1 SCREENING REAGENT LA 1 SCREENING REAGENT GIR SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH LA 1 SCREENING REAGENT 549936A 00842768007477

    Patients

    Seq Age Sex Outcome Treatment
    1