BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DADE ACTIN FSL APTT REAGENT

    MDR report key: 12615396 · Received October 12, 2021

    Report

    Report Number
    9610806-2021-00064
    Event Type
    Malfunction
    Date Received
    October 12, 2021
    Date of Event
    September 15, 2021
    Report Date
    November 1, 2021
    Product Code
    GGW
    UDI-DI
    00842768003882
    PMA / PMN Number
    K863594
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS FILED THE INITIAL MDR 9610806-2021-00064 ON 12-OCT-2021. ADDITIONAL INFORMATION (15-OCT-2021): THE ISSUE WAS ISOLATED TO ONE PATIENT SAMPLE AND NO MECHANICAL ERRORS OCCURRED AT THE TIME OF THE EVENT. THE PRECISION STUDY FOR ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) RECOVERED ACCEPTABLY. INADEQUATE REAGENT HANDLING, SAMPLE MIXING, CENTRIFUGATION OR OTHER MISHANDLING OF THE SAMPLE CANNOT BE RULED OUT AS CONTRIBUTING FACTORS TO THE EVENT. THE CUSTOMER RAN THE AFFECTED PATIENT SAMPLE AND REPORTED THE DISCORDANT RESULT WHEN QUALITY CONTROLS (QC) WERE OUT OF RANGE. THE CAUSE OF THE EVENT IS USE ERROR. THE REAGENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Additional Manufacturer Narrative · 0

    A UNITED STATES (US) CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER (CCC). QUALITY CONTROLS (QC) RECOVERED LOW AND OUT OF RANGE AT THE TIME WHEN THE DISCORDANT, FALSELY LOW APTT RESULT WAS OBTAINED. AFTER THE DISCORDANT RESULT WAS OBTAINED, THE CUSTOMER POURED FRESH DADE ACTIN FSL APTT REAGENT AND RERAN QC. THE QC THEN RECOVERED IN RANGE. A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE CSE RAN A PRECISION STUDY FOR APTT, WHICH RECOVERED ACCEPTABLY. THE CSE ALSO RERAN QC WHICH RECOVERED IN RANGE. THE SYSTEM WAS OPERATIONAL UPON THE CSE'S DEPARTURE. SIEMENS IS INVESTIGATING THE ISSUE.

    Description of Event or Problem · 0

    A DISCORDANT, FALSELY LOW ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A SYSMEX CA-660 SYSTEM USING DADE ACTIN FSL APTT REAGENT. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S). THE PATIENT'S HEPARIN DOSE WAS ADJUSTED DUE TO THE LOW APTT RESULT. THE SAMPLE WAS REPEATED THREE HOURS LATER FOR APTT, RECOVERING HIGHER. THE HIGHER RESULT WAS REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN(S). ANOTHER SAMPLE FROM THIS PATIENT HAD BEEN TESTED EARLIER IN THE MORNING FOR APTT AND HAD ALSO RECOVERED HIGHER AND BEEN REPORTED TO THE PHYSICIAN(S). LATER THAT NIGHT, A NEW SAMPLE FROM THE PATIENT WAS DRAWN AFTER THE PATIENT'S HEPARIN DOSE WAS ADJUSTED. THE SAMPLE WAS RUN FOR APTT, RECOVERING HIGHER. THIS RESULT WAS ALSO REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) OR THE CHANGE IN HEPARIN DOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1512519 DADE ACTIN FSL APTT REAGENT DADE ACTIN FSL APTT REAGENT GGW DADE ACTIN FSL APTT REAGENT 562615A 00842768003882

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR