BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOCHRON SIGNATURE ELITE

    MDR report key: 23532935 · Received November 12, 2025

    Report

    Report Number
    MW5178743
    Event Type
    Malfunction
    Date Received
    November 12, 2025
    Date of Event
    August 29, 2025
    Report Date
    November 7, 2025
    Manufacturer
    WERFEN, S.A. / ACCRIVA DIAGNOSTICS, INC.
    Product Code
    JPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2025, IN A RANDOM CHECK WE DISCOVERED THAT THE HEMOCHRON SIG ELITE INSTRUMENT (SE (B)(6)) DID NOT TRANSMIT ACT PLUS RESULTS TO COMPUTERIZED PATIENT RECORD SYSTEM (CPRS) DURING A BYPASS SURGERY ON (B)(6) 2025. DURING THE BYPASS SURGERY ON (B)(6) 2025, ANESTHESIA RECORDS INDICATED THAT ACT TESTING WAS PERFORMED AT 08:38, 11:35, 12:05, 12:35, AND 13:05. FURTHER INVESTIGATION SHOWED THAT PATIENT RESULTS AND ELECTRONIC QC RESULTS WERE ALSO MISSING FROM THE POINT OF CARE MIDDLEWARE SYSTEM (UNIPOC) ON (B)(6) 2025. THE LAST ENTRY IN THE UNIPOC DASHBOARD WAS AT 08:30 ON (B)(6)2025. THE NEXT ENTRY WAS AT 15:41 ON (B)(6) 2025. THE HEMOCHRON SIG ELITE INSTRUMENTS ARE NOT CONNECTED DIRECTLY TO THE ETHERNET. RESULTS FROM THE INSTRUMENTS ARE DOWNLOADED MANUALLY BY ANESTHESIA TECHS DAILY SO THEY CAN BE TRANSMITTED TO COMPUTERIZED PATIENT RECORD SYSTEM. ONCE THE DOWNLOADS ARE COMPLETE, ALL RESULTS IN THE INSTRUMENTS ARE AUTOMATICALLY DELETED. SINCE DATA FROM THIS PARTICULAR INSTRUMENT HAD BEEN DOWNLOADED SEVERAL TIMES BEFORE THIS INCIDENT WAS DISCOVERED, RESULTS FROM (B)(6) 2025 CANNOT BE RECOVERED. WE REQUESTED UNIPOC AND WERFEN (HEMOCHRON SIG ELITE MANUFACTURER) TECHNOLOGY SUPPORT TO INVESTIGATE THIS INCIDENT. THE FINDINGS ARE AS FOLLOWS: UNIPOC ¿ ACCORDING TO UNIPOC LOG, THERE WAS INDICATION THAT THIS INSTRUMENT ATTEMPTED TO DOWNLOAD INFORMATION TO UNIPOC ON (B)(6) 2025. HOWEVER, THE TRANSACTION WAS NEVER COMPLETED. SINCE THE TRANSACTION WAS NEVER COMPLETED, AN ACKNOWLEDGEMENT WAS NOT SENT BACK TO THE INSTRUMENT. WERFEN ¿ ACCORDING TO WERFEN, INFORMATION FROM THE INSTRUMENT IS DELETED ONCE A FORMAL ACKNOWLEDGEMENT AFTER A DOWNLOAD IS RECEIVED FROM THE MIDDLEWARE. HOWEVER, DURING REVIEW OF UNIPOCS INTERNAL LOG THERE WAS NO ACKNOWLEDGEMENT SENT TO THE INSTRUMENT. THEREFORE, RESULTS SHOULD NOT HAVE BEEN DELETED. ¿ IN ADDITION, IF THERE WAS AN INTERRUPTION DURING THE DOWNLOAD PROCESS, EVEN IF THE DOWNLOAD WAS NOT COMPLETED IT IS STILL POSSIBLE THAT RESULTS CAN BE DELETED FROM THE INSTRUMENT. AT THIS TIME, NEITHER UNIPOC NOR WERFEN COULD NOT PROVIDE ADDITIONAL FINDINGS EVEN WHEN THE INVESTIGATION HAS BEEN ESCALATED THE HIGHEST INFORMATION TECHNOLOGY LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2140090 HEMOCHRON SIGNATURE ELITE SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES JPA WERFEN, S.A. / ACCRIVA DIAGNOSTICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown