BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DADE ACTIN FSL ACTIVATED PTT REAGENT

    MDR report key: 7068659 · Received November 29, 2017

    Report

    Report Number
    9610806-2017-00138
    Event Type
    Malfunction
    Date Received
    November 29, 2017
    Date of Event
    November 2, 2017
    Report Date
    November 29, 2017
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
    Product Code
    GGW
    UDI-DI
    00842768003875
    PMA / PMN Number
    K863594
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS HEALTHCARE DIAGNOSTICS INC. (SIEMENS) CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE TO DETERMINE THE CAUSE OF THE DISCORDANT, FALSELY ELEVATED ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) RESULT ON THE SYSMEX CA-560 SYSTEM. THE CSE CHECKED THE TEMPERATURE, ALIGNMENTS, SYRINGE, PROBE, AND MIXING ON THE SYSTEM AND FOUND NO ISSUES. THE CSE RAN A PROTHROMBIN TIME (PT) PRECISION TEST AND AN APTT PRECISION TEST USING PRIMARY TUBES AND RAN QUALITY CONTROLS (QCS) ON THE SYSTEM. THE PRECISION TESTS AND QCS RECOVERED WITHIN EXPECTED RANGES. THE CSE ALSO CALIBRATED THE DETECTORS AND PERFORMED A BLEACH DRAIN ON THE SYSTEM. THE CUSTOMER INDICATED THAT THERE WERE NO HARDWARE ERRORS ON THE ERROR LIST ON THE AFFECTED SYSTEM AND THAT ALL QCS RECOVERED WITHIN RANGE SINCE THE EVENT. A SIEMENS TECHNICAL SUPPORT SPECIALIST (TST) DISCUSSED PROPER MIXING OF SAMPLE TUBES WITH THE CUSTOMER. THE CUSTOMER INDICATED THAT, AT THEIR SITE, ONLY PHLEBOTOMISTS DRAW PATIENTS' BLOOD AND THEY ARE TAUGHT TO INVERT THE TUBE 5-10 TIMES AFTER DRAWING THE PATIENT SAMPLE. A SAMPLE HANDLING OR COLLECTION ISSUE MAY HAVE CONTRIBUTED TO THE DISCORDANT APTT RESULT ON THE PATIENT SAMPLE. IMPROPER MIXING POST BLOOD DRAW MAY HAVE CAUSED POOR ANTICOAGULATION OR ANTICOAGULANT TO BE IN THE UPPER PORTION OF THE PLASMA SAMPLE, POTENTIALLY CAUSING THE DISCORDANT PROLONGED CLOT TIME. WHEN THE PLASMA WAS TRANSFERRED TO THE SAMPLE CUP, THIS INDUCED ADDITIONAL MIXING, POTENTIALLY LEADING TO A LOWER RESULT. THE CAUSE OF THE DISCORDANT, FALSELY ELEVATED APTT RESULT IS UNKNOWN. THE SYSTEM AND REAGENT ARE PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS SYSTEM OR REAGENT IS REQUIRED. MDR 9610806-2017-00137 WAS FILED FOR THE SAME EVENT.

    Description of Event or Problem · 1

    A DISCORDANT, FALSELY ELEVATED ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) RESULT WAS OBTAINED ON A PATIENT SAMPLE TUBE ON THE SYSMEX CA-560 SYSTEM. THIS DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN, WHO DID NOT QUESTION THE RESULT. THE SAME SAMPLE WAS TRANSFERRED TO A SAMPLE CUP AND RERUN ON THE SAME SYSTEM, RESULTING LOWER. THE PATIENT'S BLOOD WAS REDRAWN AND RUN IN A PRIMARY TUBE AND IN A SAMPLE CUP ON THE SAME SYSTEM, RESULTING LOWER THAN THE INITIAL RESULT. THE APTT RESULT OBTAINED ON THE REDRAWN SAMPLE TUBE WAS REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED APTT RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848310 DADE ACTIN FSL ACTIVATED PTT REAGENT DADE ACTIN FSL ACTIVATED PTT REAGENT GGW SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH DADE ACTIN FSL ACTIVATED PTT REAGENT 547496A 00842768003875

    Patients

    Seq Age Sex Outcome Treatment
    1