BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LA 1 SCREENING REAGENT

    MDR report key: 7339668 · Received March 14, 2018

    Report

    Report Number
    9610806-2018-00032
    Event Type
    Malfunction
    Date Received
    March 14, 2018
    Date of Event
    February 6, 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

    A SIEMENS HEADQUARTERS SUPPORT CENTER (HSC) SPECIALIST CONTACTED THE CUSTOMER TO INVESTIGATE THE CAUSE OF THE 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 DID NOT OBSERVE ANY SYSTEM FLAG WHEN THE DISCORDANT RESULT WAS OBTAINED. THE CUSTOMER RECEIVED 5 SAMPLE TUBES FROM THIS PATIENT AND WAS NOT ABLE TO CORRELATE THE RESULT TO A SPECIFIC SAMPLE COLLECTION TUBE AND TIME. 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. THE HSC SPECIALIST WAS NOT ABLE TO IDENTIFY THE DATA FOR THIS PATIENT IN THE SYSTEM'S BACKUP FILES. THE HSC SPECIALIST DETERMINED THAT THE CAUSE OF THE DISCORDANT, FALSELY ELEVATED LA 1 SCREENING REAGENT CLOTTING TIME RESULT WAS POTENTIALLY DUE TO A SAMPLE HANDLING OR COLLECTION ISSUE. THE CAUSE OF THE DISCORDANT RESULT ON THIS PATIENT CANNOT BE DETERMINED SINCE THE CUSTOMER DID NOT WANT TO FURTHER INVESTIGATE THIS SAMPLE. THE SYSTEMS AND REAGENT ARE PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THESE SYSTEMS AND REAGENT IS REQUIRED. MDR 9610806-2018-00033 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 THIS, 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). A SAMPLE FROM THE SAME PATIENT WAS RUN ON AN ALTERNATE BCS XP SYSTEM AND LOWER LA 1 SCREENING REAGENT CLOTTING TIME AND LA 2 CONFIRMATION CLOTTING TIME RESULTS WERE OBTAINED ON THE PATIENT SAMPLE. IT IS UNKNOWN IF THE INITIAL RESULTS AND REPEAT RESULTS WERE OBTAINED USING THE SAME SAMPLE. THE RESULT OF 39.3 SECONDS 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
    180415 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