BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOCHRON SIGNATURE ELITE MICROCOAGULATION SYSTEM

    MDR report key: 8186223 · Received December 20, 2018

    Report

    Report Number
    2250033-2018-00028
    Event Type
    Malfunction
    Date Received
    December 20, 2018
    Date of Event
    December 12, 2018
    Report Date
    January 16, 2019
    Manufacturer
    ACCRIVA DIAGNOSTICS
    Product Code
    JPA
    UDI-DI
    10711234510018
    PMA / PMN Number
    K050016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MDR NUMBER 2250033-2018-00028 FOLLOW-UP #1 PROVIDES THE RESULTS OF THE INSTRUMENT AND DISPOSABLE EVALUATION FOR THE HEMOCHRON SIGNATURE ELITE INSTRUMENT, SERIAL NUMBER (B)(6), THE PARENT CASE, AND CHILD CASE 181287 CAPTURING JACT-LR CUVETTE LOT E8JLR108. METHOD CODE: 10 ACTUAL DEVICE WAS EVALUATED PER LSR 2018-CSS-040. RESULTS CODE: 213 LIQUID QC WAS TESTED ON SE13866 AND TWO COMPARATOR SIGNATURE ELITES. RESULTS WERE WITHIN 10% OF THE MEAN AND MET PRECISION SPECIFICATIONS. ELECTRONIC QC WAS TESTED AT TWO LEVELS AND PASSED. REPLICATE MEASURMENTS OF DONOR WHOLE BLOOD WERE ASSAYED NEAT AND AFTER SPIKED WITH TWO CONCENTRATIONS OF HEPARIN. RESULTS GENERATED FROM RETAINS OF JACT-LR LOT E8JLR108 SHOWED A %CVS OF <10%, WHICH MET THE PRE-SPECIFIED REQUIREMENT FOR PRECISION. CONCLUSIONS CODE: 67 NO PROBLEM DETECTED. THIS SUBMISSION PROVIDES CLOSURE TO THIS COMPLAINT AND SERVES AS THE FINAL MDR.

    Description of Event or Problem · 0

    FOLLOW-UP #1.

    Additional Manufacturer Narrative · 1

    THIS MDR REFERENCES ACCRIVA DIAGNOSTICS' COMPLAINT NUMBER (B)(4) FOR THE HEMOCHRON SIGNATURE ELITE, SERIAL NUMBER (B)(4), THE PARENT CASE. THIS MDR ALSO CAPTURES A CHILD COMPLAINT (B)(4) FOR THE LOT OF HEMOCHRON ACT-LR (LOW-RANGE) REAGENT CUVETTES USED DURING THE PROCEDURE. ACCRIVA DIAGNOSTICS HAS REQUESTED ALL DATA REQUIRED FOR FORM 3500A. THIS IS THE INITIAL 30-DAY REPORT THAT PRECEDES THE INSTRUMENT EVALUATION. FOLLOW-UP #1 WILL BE SUBMITTED AFTER THE DEVICE IS RETURNED TO THE MANUFACTURER AND THE EVALUATION IS COMPLETED.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED THAT A HEMOCHRON SIGNATURE ELITE AND LOW-RANGE ACT SYSTEM REPORTED INCONSISTENT PATIENT RESULTS DURING A PCI PROCEDURE AND CORONARY ARTERY STENT PLACEMENT. THE PATIENT WAS RECEIVING INTRAVENOUS HEPARIN WITH A TARGET ACT OF >250 SECONDS. THE SECOND AND FOURTH BLOOD SAMPLES GENERATED ACT RESULTS OF 336 AND 343 SECONDS, RESPECTIVELY, WHICH WERE AS EXPECTED. HOWEVER, THE THIRD AND FIFTH BLOOD SAMPLES GENERATED ACT RESULTS OF 239 AND 287 SECONDS, RESPECTIVELY, WHICH WERE LOWER THAN THE TARGER ACT OF >250 SECONDS. A REVIEW OF THE SAMPLE COLLECTION, SAMPLE WASTE, SAMPLE DISPENSING AND TEST PROCEDURES PERFORMED AT THE HEALTHCARE FACILITY WERE IN CONFORMANCE WITH THE JACT-LR INSTRUCTIONS FOR USE AND THE HEMOCHRON SIGNATURE ELITE OPERATOR MANUAL. NO OTHER ANTICOAGULANTS (ANTIPLATELET AGENTS, LOW MOLECULAR WEIGHT HEPARINS OR DIRECT THROMBIN INHIBITORS) WERE USED DURING THE PCI AND STENT PLACEMENT. ELECTRONIC AND LIQUID QC PASSED PRIOR TO THE PROCEDURE. NO BLEEDING OR MEDICAL COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1024833 HEMOCHRON SIGNATURE ELITE MICROCOAGULATION SYSTEM SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES JPA ACCRIVA DIAGNOSTICS ELITE 10711234510018

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR JACT-LR CUVETTE LOT E8JLR108