BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEMOCHRON ACTIVATED CLOTTING TIME PLUS (ACT+) TEST

    MDR report key: 20295483 · Received September 24, 2024

    Report

    Report Number
    2250033-2024-00002
    Event Type
    Death
    Date Received
    September 24, 2024
    Date of Event
    August 22, 2024
    Report Date
    March 7, 2025
    Manufacturer
    ACCRIVA DIAGNOSTICS, INC.
    Product Code
    JBP
    UDI-DI
    10711234103067
    PMA / PMN Number
    K941007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR REFERENCES ACCRIVA DIAGNOSTICS' COMPLAINT NUMBER (B)(4) FOR HEMOCHRON JACT+ CUVETTE LOT D3JAC095 WITH A LABELED EXPIRATION DATE OF 07/31/2024. THE CUVETTE WAS USED WITH A HEMOCHRON SIGNATURE ELITE INSTRUMENT DURING THE PROCEDURE. THE SERIAL NUMBER OF THE SIGNATURE ELITE INSTRUMENT WAS NOT SPECIFIED. THE END USER SUSPECTS THE ISSUE MAY BE RELATED TO IMPROPER SAMPLE HANDLING OR COLLECTION PROCEDURES. DHR REVIEW OF JACT+ LOT D3JAC095 PRODUCTION RECORDS DID NOT REVEAL ANY NONCONFORMITIES OR ANOMALIES THAT COULD HAVE BEEN A FACTOR FOR OR A POTENTIAL ROOT CAUSE OF THE ALLEGATION. RELEASE TESTING OF THE CUVETTE LOT MET ALL SPECIFICATIONS. RETAINS OF JACT+ CUVETTE LOT D3JAC095 WERE TESTED UNDER LSR 2024-CSS-110 AND THE DEVICE PERFORMED WITHIN EXPECTATIONS. THE HEMOCHRON SIGNATURE ELITE INSTRUMENT WAS NOT RETURNED TO ACCRIVA DIAGNOSTICS, INC. FOR EVALUATION SO NO FURTHER INFORMATION IS AVAILABLE. HEALTH EFFECT CLINICAL CODE: 2493, ISCHEMIC HEART DISEASE. HEALTH EFFECT IMPACT CODE: 1802, DEATH. DEVICE PROBLEM CODE: 2993, ADVERSE EVENT WITHOUT IDENTIFIED DEVICE OR USE PROBLEM. COMPONENT CODE: 4765, CUVETTE. TYPE OF INVESTIGATION: 3331, ANALYSIS OF PRODUCTION RECORDS; 4114: DEVICE NOT RETURNED. INVESTIGATION FINDINGS: 213, NO DEVICE PROBLEM FOUND. INVESTIGATION CONCLUSIONS: 4310, CAUSE TRACED TO NON-DEVICE RELATED FACTORS. ACCRIVA DIAGNOSTICS, INC. HAS REQUESTED ALL DATA REQUIRED FOR FORM 3500A.

    Additional Manufacturer Narrative · 0

    SUBSEQUENT TO THE MDR INITIAL REPORT, THE CUSTOMER PROVIDED THE SERIAL NUMBER OF THE SIGNATURE ELITE INSTRUMENT (B)(6) BUT DID NOT RETURN THE DEVICE TO ACCRIVA DIAGNOSTICS FOR TESTING. ACCRIVA DIAGNOSTICS REVIEWED THE DHR (PRODUCTION RECORDS) AND SERVICE RECORDS FOR (B)(6) AND FOUND NO ANOMALIES OR HISTORY OF MALFUNCTIONS THAT COULD HAVE CONTRIBUTED TO THE ALLEGED ERROR.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED THAT A HEMOCHRON SIGNATURE ELITE ANALYZER AND ACT+ TEST DEVICE WAS USED TO MONITOR HEPARIN ANTICOAGULATION IN A PATIENT THAT WAS UNDERGOING A CORONARY ANGIOPLASTY PROCEDURE. ACT TEST RESULT OBTAINED AT BASELINE WAS NOT SPECIFIED. THE PATIENT RECEIVED CLOPIDOGREL BY MOUTH AND WAS GIVEN A 5000U INTRAVENOUS DOSE OF HEPARIN. THE RESULT OF AN ACT TEST OBTAINED 1 HOUR AFTER HEPARIN ADMINISTRATION WAS OUT-OF-RANGE HIGH. THE PATIENT EXPIRED DUE TO A SLOW HEART RATE AT AN UNSPECIFIED TIME. NO OTHER MEDICAL OR LABORATORY INFORMATION WAS SPECIFIED. ELECTRONIC QUALITY CONTROL (EQC) TESTING PERFORMED PRIOR TO THE PROCEDURE PASSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1092497 HEMOCHRON ACTIVATED CLOTTING TIME PLUS (ACT+) TEST ACTIVATED WHOLE BLOOD CLOTTING TIME JBP ACCRIVA DIAGNOSTICS, INC. D3JAC095 10711234103067

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Death CLOPIDOGREL