BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOCHRON¿ WHOLE BLOOD MICROCOAGULATION SYSTEM-HEMOCHRON SIGNATURE ELITE INSTR

    MDR report key: 23215909 · Received October 3, 2025

    Report

    Report Number
    0002250033-2025-00002
    Event Type
    Malfunction
    Date Received
    October 3, 2025
    Date of Event
    September 5, 2025
    Report Date
    October 3, 2025
    Manufacturer
    ACCRIVA DIAGNOSTICS, INC.
    Product Code
    JPA
    PMA / PMN Number
    K193041
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 SE11169 AND HEMOCHRON JACT-LR CUVETTE LOT D5JLR104 USED DURING THE PROCEDURE WITH A LABELED EXPIRATION DATE OF 07/31/2026. DHR REVIEW OF JACT-LR CUVETTES LOT D5JLR104 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. A REVIEW OF IN-HOUSE TESTING PERFORMED ON RETAINS OF THE ASSOCIATED CUVETTE LOT SHOWED THAT THE CUVETTES PERFORMED AS EXPECTED BASED ON ESTABLISHED SPECIFICATIONS: CUVETTE LOT D5JLR104 TESTED UNDER LSR 2025-CSS-118. THE INSTRUMENT WAS RETURNED TO ACCRIVA DIAGNOSTICS ON 09-10-25 FOR EVALUATION. IN-HOUSE QUALITY CONTROL TESTING WAS PERFORMED ON THE INSTRUMENT AND PASSED ALL TEST CRITERIA. NO ERRORS OCCURRED DURING QC TESTING, AND THE COMPLAINT COULD NOT BE DUPLICATED. AFTER QC TESTING, THE INSTRUMENT WAS SENT TO THE SERVICE DEPARTMENT FOR FURTHER EVALUATION. DURING THIS ASSESSMENT, THE PUMPS WERE OBSERVED TO BE OPERATING INTERMITTENTLY. OUT OF AN ABUNDANCE OF CAUTION, THE PUMPS WERE PROACTIVELY REPLACED. FOLLOWING REPLACEMENT, THE INSTRUMENT PERFORMED TO SPECIFICATION. A REVIEW OF DHR AND SERVICE RECORDS OF THE HEMOCHRON SIGNATURE ELITE INSTRUMENT SE11169 REVEALED PREVIOUS PUMP ANOMALIES REQUIRING REPAIR. ACCRIVA HAS REQUESTED ALL DATA REQUIRED FOR FORM 3500A. FIELDS FOR WHICH DATA WERE NOT OBTAINABLE OR ARE NOT APPLICABLE ARE INTENTIONALLY LEFT BLANK: A1-A3,A5-A6, D6, D7B, F1-F14, G5, G7, G9.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED THAT A HEMOCHRON SIGNATURE ELITE AND LOW RANGE ACT ASSAY WAS USED DURING A CORONARY ANGIOGRAM WITH PERCUTANEOUS CORONARY INTERVENTION. THE END USER IS QUESTIONING TWO SAMPLE RESULTS OF >400 SECONDS. TARGET TIME WAS >250 SEC. NO BASELINE ACT MEASUREMENT WAS PERFORMED. DURING THE PROCEDURE, A CLOT WAS OBSERVED. NO ADVERSE EVENTS OR ADDITIONAL MEDICAL INTERVENTION WAS REPORTED. THE END USER REPORTED THAT THE INSTRUMENT EQC AND LQC PASSED ALL TESTS. THE CONDITION OF THE PATIENT IS UNKNOWN. NO PATIENT INFORMATION OTHER THAN BODY WEIGHT (67.4KG) 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
    1587692 HEMOCHRON¿ WHOLE BLOOD MICROCOAGULATION SYSTEM-HEMOCHRON SIGNATURE ELITE INSTR HEMOCHRON¿ SIGNATURE ELITE JPA ACCRIVA DIAGNOSTICS, INC. ELITE

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other HEPARIN 4000 UNITS @ 0844 AM.