BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DADE ACTIN FSL ACTIVATED PTT REAGENT

    MDR report key: 8032166 · Received November 2, 2018

    Report

    Report Number
    9610806-2018-00113
    Event Type
    Malfunction
    Date Received
    November 2, 2018
    Date of Event
    October 8, 2018
    Report Date
    November 2, 2018
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
    Product Code
    GGW
    PMA / PMN Number
    K863594
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER (CCC) AND REPORTED THAT QUALITY CONTROL (QCS) RECOVERED OUT OF RANGE(S) FOR D-DIMER AND ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) ON THE SYSMEX CS-2500 SYSTEM. WHILE NO PATIENT SAMPLES WERE RUN FOR D-DIMER WHEN QCS RECOVERED OUT OF RANGES, DISCORDANT, FALSELY ELEVATED APTT RESULTS WERE OBTAINED ON PATIENT SAMPLES. THERE WERE NO REPORTS OF SYSTEM ERRORS GENERATED WHEN THE DISCORDANT APTT RESULTS WERE OBTAINED. A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER'S SITE. THE CSE REPORTED THAT THE ISSUE WAS RESOLVED BEFORE HE ARRIVED AND WHEN THE CSE RAN QCS, THE QCS RECOVERED WITHIN ACCEPTABLE RANGES FOR D-DIMER AND APTT. THE CSE INSPECTED THE MECHANICAL POSITIONS ON THE SYSTEM AND DETERMINED THAT ADJUSTMENTS WERE NOT REQUIRED. THEN, THE CSE OBSERVED AN ERROR IN SYSTEM'S ERROR LOG ("ERROR IN HYDRAULIC LINE FOR RINSE CUP EJECTION IN SAMPLE PROBE") AND DETERMINED THAT THE SAMPLE CUP RINSE WAS NOT BEING DRAINED FAST ENOUGH, CAUSING AN OVERFLOW; THE CSE BLEACHED VALVE 2 AND THE RINSE DRAIN OPERATED ACCEPTABLY. THE CSE REPORTED THAT QCS WERE WITHIN ACCEPTABLE RANGES PRIOR TO AND AFTER THE CSE BLEACHED VALVE 2. SIEMENS FURTHER INVESTIGATED THE ISSUE AND DETERMINED THAT THE SAMPLE CUP RINSE OVERFLOW MAY HAVE CONTRIBUTED TO THE DISCORDANT, FALSELY ELEVATED APTT RESULTS. SIEMENS REACHED OUT TO THE CUSTOMER WITH QUESTIONS REGARDING THE AFFECTED PATIENT SAMPLES AND IMPACTED REAGENT LOTS, AND HOW THE ISSUE WAS RESOLVED PRIOR TO THE CSE'S VISIT; HOWEVER, THE CUSTOMER HAS NOT RESPONDED THUS FAR. THE LOT NUMBER AND UNIQUE IDENTIFIER NUMBER (UDI) FOR THE DADE ACTIN FSL ACTIVATED PTT REAGENT WERE NOT AVAILABLE AT THE TIME OF FILING THIS MDR. THE REAGENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT, FALSELY ELEVATED ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) RESULTS WERE INTERMITTENTLY OBTAINED ON PATIENT SAMPLES ON A SYSMEX CS-2500 SYSTEM, USING THE DADE ACTIN FSL ACTIVATED PTT REAGENT, ON (B)(6) 2018. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). WHEN THE SAMPLES WERE REPEATED ON AN ALTERNATE SYSMEX CA-1500 SYSTEM, LOWER RESULTS WERE OBTAINED ON THE SAMPLES. THE REPEAT RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THE CUSTOMER REPORTED THAT THEY TRANSFERRED ALL PATIENT SAMPLES TO THE SYSMEX CA-1500 SYSTEM FOR TESTING. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED APTT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    872054 DADE ACTIN FSL ACTIVATED PTT REAGENT DADE ACTIN FSL ACTIVATED PTT REAGENT GGW SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH DADE ACTIN FSL ACTIVATED PTT REAGENT

    Patients

    Seq Age Sex Outcome Treatment
    1