MAUDE Adverse Event Report: ACCRIVA DIAGNOSTICS, INC. HEMOCHRON WHOLE BLOOD MICROCOAGULATION SYSTEM - HEMOCHRON SIGNATURE ELITE INSTR

Model Number	ELITE
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/04/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
This mdr references accriva diagnostics' complaint number (b)(4) for the hemochron whole blood microcoagulation system - hemochron signature elite instrument (b)(6).The instrument has no expiration date.Analysis of production records did not provide any information relevant to this complaint.The dhr for elite instrument (b)(6) was reviewed and analyzed for potential non-conformities, or anomalies, which could have led to this complaint allegation.Review and analysis indicated no non-conformities or anomalies that can be a factor or a potential root cause to the aforementioned allegation.The product initial release testing was found to meet all specifications.Accriva diagnostics, inc.Has requested further information from the reporter and is awaiting a response.
Event or Problem Description
Healthcare professional reported that a hemochron signature elite analyzer was used on several patient cases where they observed unexpected results.These cases involved patients who went into arrest.One patient could not be resuscitated, resulting in death.No additional details or patient information are available at this time.
Additional Manufacturer Narrative
Follow-up 1: following the initial mdr report, hemochron signature elite instrument se12657 was returned to accriva for evaluation.The instrument was tested and met all test criteria.No errors occurred during testing, and the complaint could not be reproduced.In addition, a review of in-house testing performed on retains of the associated cuvette lots showed that the cuvettes performed as expected based on established specifications: cuvette lot a5jlr015 tested under lsr 2025-css-058, and cuvette lot a5jlr011 tested under lsr 2025-css-050.Based on the investigation findings and the information available, the adverse event problem codes have been updated as follows: health effect clinical code (e): 4580 - insufficient information.Health effect impact code (f): 1802 - death.Medical device problem code (a): 3190 - insufficient information.Component code (g): 593 - analyzer.Type of investigation (b): 10 - testing of actual/suspected device; 3331 - analysis of production records.Investigation findings (c): 213 - no device problem found.Investigation conclusions (d): 4315 - cause not established.The number of patients affected remains unconfirmed as the initial reporter has not responded to accriva's request for this information.
Event or Problem Description
Healthcare professional reported that a hemochron signature elite analyzer was used on several patient cases where they observed unexpected results.These cases involved patients who went into arrest.One patient could not be resuscitated, resulting in death.The number of patients involved was not specified.The patient who passed away was undergoing a coronary intervention procedure.No error codes were seen from the instrument, and electronic quality control (eqc) and liquid quality control (lqc) testing passed.No other medical or laboratory information was provided.

• Brand Name: HEMOCHRON WHOLE BLOOD MICROCOAGULATION SYSTEM - HEMOCHRON SIGNATURE ELITE INSTR
• Common Device Name: HEMOCHRON SIGNATURE ELITE
• Manufacturer (Section D): ACCRIVA DIAGNOSTICS, INC.; 6260 sequence drive; san diego CA 92121
• Manufacturer (Section G): ACCRIVA DIAGNOSTICS, INC.; 6260 sequence drive; san diego CA 92121
• Manufacturer Contact: wenni haley ; 6260 sequence drive; san diego, CA 92121 ; 8582632322
• MDR Report Key: 22375004
• Report Number: 2250033-2025-00001
• Device Sequence Number: 17246594
• Product Code: JPA
• UDI-Device Identifier: 10711234510018
• UDI-Public: 10711234510018
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K193041
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: ELITE
• Device Catalogue Number: ELITE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/01/2025
• Supplement Report FDA Received Date: 07/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown
• Patient Weight: 100 KG