BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DADE ACTIN FSL ACTIVATED PTT REAGENT

    MDR report key: 7962392 · Received October 12, 2018

    Report

    Report Number
    9610806-2018-00105
    Event Type
    Malfunction
    Date Received
    October 12, 2018
    Date of Event
    September 19, 2018
    Report Date
    October 12, 2018
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCT GMBH
    Product Code
    GGW
    UDI-DI
    00842768003882
    PMA / PMN Number
    K863594
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER (CCC) AND INDICATED THAT THEY OBTAINED DISCORDANT ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) RESULTS ON A PATIENT SAMPLE USING THE DADE ACTIN FSL ACTIVATED PTT REAGENT. AS PER SIEMENS' INSTRUCTIONS, THE CUSTOMER PERFORMED A PRECISION STUDY USING QUALITY CONTROLS, RESULTING ACCEPTABLY. SIEMENS INVESTIGATED THE INSTRUMENT FILES AND OBSERVED THAT THE SAMPLES WERE FLAGGED WITH ERR 128 (EARLY REACTION ERROR) AND ERR 004 (ANALYSIS TIME OVER). THE SYSMEX CA-1500 SYSTEM ADVISES CUSTOMERS THAT AN ABNORMAL REACTION WAS DETECTED AT THE INITIAL STAGE OF THE COAGULATION BECAUSE OF A REAGENT PROBLEM AND TO CHECK THE COAGULATION CURVE, INCREASE THE MAXIMUM DETECTION TIME AND CHECK THE STATUS OF THE SAMPLE AND REAGENT FOR RE-ANALYSIS WHEN THESE ERRORS ARE TRIGGERED DURING SAMPLE ANALYSIS. QUALITY CONTROLS (QCS) RECOVERED WITHIN LAB RANGES ON THE DAY OF THE EVENT. THE CUSTOMER SUSPECTED THAT THE SAMPLES WERE CONTAMINATED. SIEMENS FURTHER INVESTIGATED THE EVENT AND DETERMINED THAT THERE WERE NO MECHANICAL OR ANALYSIS ERRORS, INDICATING THERE WERE NO SYSTEM MALFUNCTIONS. SIEMENS CONCLUDED THAT THE CAUSE OF THE DISCORDANT, FALSELY LOW APTT RESULT WAS SAMPLE SPECIFIC AND WAS POTENTIALLY CAUSED BY PRE-ANALYTICAL FACTORS. THE SYSTEM AND REAGENT ARE PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THESE DEVICES IS REQUIRED. MDR 9610806-2018-00104 WAS FILED FOR THE SAME ISSUE.

    Description of Event or Problem · 1

    A FLAGGED, ELEVATED ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) RESULT WAS OBTAINED ON A PATIENT SAMPLE USING THE DADE ACTIN FSL ACTIVATED PTT REAGENT ON A SYSMEX CA-1500 SYSTEM. THE SAMPLE WAS REPEATED ON AN ALTERNATE SYSMEX CA-1500 SYSTEM USING THE SAME REAGENT LOT, RESULTING IN ANOTHER ELEVATED APTT RESULT. THE SAMPLE WAS REPEATED ON THE INITIAL SYSTEM AND A DISCORDANT, FALSELY LOW RESULT WAS OBTAINED. THE SAMPLE WAS REPEATED TWICE ON THE ALTERNATE SYSTEM, RESULTING IN FLAGGED, ELEVATED APTT RESULTS. THE CUSTOMER REPORTED THE APTT RESULT OF >200 SECONDS, AS THE CORRECT RESULT, TO THE PHYSICIAN(S). THE PATIENT WAS REDRAWN AND THE NEW SAMPLE WAS RUN ON ONE OF THE SYSTEMS; A RESULT OF >200 SECONDS WAS OBTAINED ON THE RE-DRAWN SAMPLE. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW APTT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    800468 DADE ACTIN FSL ACTIVATED PTT REAGENT DADE ACTIN FSL ACTIVATED PTT REAGENT GGW SIEMENS HEALTHCARE DIAGNOSTICS PRODUCT GMBH DADE ACTIN FSL ACTIVATED PTT REAGENT 556922A 00842768003882

    Patients

    Seq Age Sex Outcome Treatment
    1