BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOCHRON SIGNATURE ELITE MICROCOAGULATION SYSTEM

    MDR report key: 7310690 · Received March 2, 2018

    Report

    Report Number
    2250033-2018-00006
    Event Type
    Malfunction
    Date Received
    March 2, 2018
    Date of Event
    February 6, 2018
    Report Date
    April 16, 2018
    Manufacturer
    ACCRIVA DIAGNOSTICS
    Product Code
    JPA
    PMA / PMN Number
    K050016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MDR 2250033-2018-00006 FOLLOW-UP #1 REPORTS RESULTS OF THE INSTRUMENT EVALUATION ON THE HEMOCHRON SIGNATURE ELITE MICROCOAGULATION SYSTEM SERIAL NUMBER (B)(4) NAMED IN ACCRIVA DIAGNOSTICS' COMPLAINT (B)(4). THE ACTUAL DEVICE WAS EVALUATED. NO FAILURE DETECTED. NO FAILURE DETECTED, DEVICE OPERATED WITHIN SPECIFICATION WHEN LIQUID QUALITY CONTROL MATERIALS AND BLOOD SAMPLES WERE ASSAYED. UNABLE TO CONFIRM COMPLAINT. ACCRIVA DIAGNOSTICS HAS REQUESTED ALL DATA REQUIRED FOR FORM FDA 3500-A. NO PREVIOUSLY UNOBTAINABLE INFORMATION REPORTED IN THE INITIAL MDR IS AVAILABLE.

    Description of Event or Problem · 0

    FOLLOW-UP #1.

    Additional Manufacturer Narrative · 1

    THIS MDR REFERENCES (B)(4) FOR THE HEMOCHRON SIGNATURE ELITE INSTRUMENT, SERIAL NUMBER (B)(4). ACTUAL DEVICE NOT EVALUATED. PROCESS EVALUATION PERFORMED. THE PCB BOARD, COVERS AND BATTERY WERE REPLACED IN 2010, BUT THE REASON FOR THAT SERVICE IS NOT RELATED TO THE CURRENT COMPLAINT. NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED. DEVICE NOT RETURNED. ACCRIVA DIAGNOSTICS HAS REQUESTED ALL DATA REQUIRED FOR FORM 3500A. FIELDS FOR WHICH DATA WERE NOT OBTAINABLE OR ARE NOT APPLICABLE ARE INTENTIONALLY LEFT BLANK. AN INSTRUMENT EVALUATION IS ANTICIPATED. RESULTS OF THE EVALUATION WILL BE SUBMITTED AS MDR 2250033-2018-00006 FOLLOW-UP #1.

    Description of Event or Problem · 1

    A HEALTHCARE PROFESSIONAL REPORTED DISCREPANT ACT RESULTS WITH TWO DIFFERENT HEMOCHRON SIGNATURE ELITE AND ACT+ MICROCOAGULATION SYSTEMS AT THE CONCLUSION OF A CARDIOVASCULAR PROCEDURE. THE SIGNATURE ELITE NAMED IN THIS COMPLAINT WAS USED DURING THE PROCEDURE AND THE ACT RESULTS RECORDED WERE AS EXPECTED. AFTER PROTAMINE WAS GIVEN THE ACT RESULT WAS 380 SECONDS, WHICH WAS HIGHER THAN EXPECTED. ANOTHER BLOOD DRAW WAS DONE AND SPLIT SAMPLES WERE RUN ON THE THE SAME ELITE AND ON A SECOND ELITE SYSTEM. THE RECORDED ACT RESULTS WERE 408 AND 134 SECONDS, RESPECTIVELY. THE RESULT OF 134 SECONDS WAS AS EXPECTED. THE PROCEDURE WAS COMPLETED AND NO ADVERSE EVENTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152789 HEMOCHRON SIGNATURE ELITE MICROCOAGULATION SYSTEM SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES JPA ACCRIVA DIAGNOSTICS ELITE

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR HEMOCHRON JR ACT+ CUVETTE, LOT K7JAC404