BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMOCHRON WHOLE BLOOD MICROCOAGULATION SYSTEM

    MDR report key: 18984075 · Received March 26, 2024

    Report

    Report Number
    2250033-2024-00001
    Event Type
    Injury
    Date Received
    March 26, 2024
    Date of Event
    February 28, 2024
    Report Date
    March 26, 2024
    Manufacturer
    ACCRIVA DIAGNOSTICS, INC.
    Product Code
    JPA
    UDI-DI
    10711234510018
    PMA / PMN Number
    K193041
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR REFERENCES ACCRIVA DIAGNOSTICS' COMPLAINT NUMBER (B)(4) FOR THE HEMOCHRON WHOLE BLOOD MICROCOAGULATION SYSTEM - SIGNATURE ELITE INSTRUMENT (B)(6) AND HEMOCHRON JACT-LR CUVETTE LOT L3JLR256 USED DURING THE PROCEDURE HAS A LABELED EXPIRATION DATE OF 02/28/2025. ON (B)(6) 2024, AN ACCRIVA (WERFEN) APPLICATION SPECIALIST VISITED THE CUSTOMER TO INVESTIGATE THE ANALYZER ALLEGED IN THE COMPLAINT. THE SPECIALIST PERFORMED QC TESTING AND THE DEVICE PASSED ALL TESTS, VISIBLY, THE ANALYZER APPEARED IN GOOD CONDITION WITH NO VISIBLE FAULTS. END USER REPORTED THAT THE ELITE HAD NOT RECENTLY DISPLAYED ANY ERRORS. REVIEW OF PRODUCTION RECORDS DID NOT PROVIDE ANY INFORMATION RELEVANT TO THIS COMPLAINT. RETAINS OF JACT-LR CUVETTE LOT L3JLR256 WERE TESTED AND PERFORMED WITHIN EXPECTATIONS. DHR REVIEW OF ELITE (B)(6) 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 ELITE MET ALL SPECIFICATIONS. THE DEVICE WAS NOT RETURNED TO ACCRIVA FOR EVALUATION SO NO FURTHER INFORMATION IS AVAILABLE. DHR REVIEW OF JACT-LR LOT F3JLR256 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. HEALTH EFFECT CLINICAL CODE: 1969, MYOCARDIAL INFARCTION. HEALTH EFFECT IMPACT CODE: 4614, SERIOUS INJURY/ILLNESS/IMPAIRMENT; 4641: UNEXPECTED MEDICAL INTERVENTION. DEVICE PROBLEM CODE: 2993, ADVERSE EVENT WITHOUT IDENTIFIED DEVICE OR USE PROBLEM. COMPONENT CODE: 593, ANALYZER. TYPE OF INVESTIGATION: 3331, ANALYSIS OF PRODUCTION RECORDS; 4114: DEVICE NOT RETURNED. INVESTIGATION FINDINGS: 3221, NO FINDINGS AVAILABLE. INVESTIGATION CONCLUSIONS: 4315, CAUSE NOT ESTABLISHED. 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: A1, A2, A3A, A3B, A5, A6, B6A, B6B, AND B7.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED THAT A HEMOCHRON SIGNATURE ELITE ANALYZER AND LOW RANGE ACT ASSAY WAS USED IN THE CATH LAB FOR MONITORING HEPARIN DURING AN UNSPECIFIED PROCEDURE. TARGET ACT WAS 245-250 SEC. NO BASELINE ACT MEASUREMENT WAS DONE. DURING THE PROCEDURE, A CLOT WAS OBSERVED ON THE GUIDE WIRE WHICH WAS SUCESSFULLY TREATED WITH THROMBOLYTIC THERAPY. THE END USER EXPRESSED CONCERN THAT THE HEMOCHRON SIGNATURE ELITE POSSIBLY OVERESTIMATED THE ACT RESULT THEREBY LEADING TO POSSIBLE UNDER HEPARINIZATION OF THE PATIENT. THE PHYSICIAN CLAIMED THE PATIENT HAD A MINOR MYOCARDIAL INFARCTION DUE TO CLOT MIGRATION. THE PATIENT WAS DISCHARGED IN GOOD CONDITION. NO PATIENT INFORMATION OTHER THAN BODY WEIGHT (184.97 LBS.) HAS BEEN PROVIDED. NO INFORMATION IS AVAILABLE REGARDING COMORBID CONDITIONS OR PAST HEALTH HISTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528051 HEMOCHRON WHOLE BLOOD MICROCOAGULATION SYSTEM SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES JPA ACCRIVA DIAGNOSTICS, INC. ELITE 10711234510018

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention HEPARIN 500U @ 0853, 1000U @0906, 3000U @1008.