MAUDE Adverse Event Report: ACCRIVA DIAGNOSTICS, INC. HEMOCHRON ACTIVATED CLOTTING TIME PLUS (ACT+) TEST; ACTIVATED WHOLE BLOOD CLOTTING TIME

Catalog Number	JACT+
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Ischemic Heart Disease (2493)
Date of Event	08/22/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
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.
Event or Problem Description
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.
Additional Manufacturer Narrative
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.

• Brand Name: HEMOCHRON ACTIVATED CLOTTING TIME PLUS (ACT+) TEST
• Common Device Name: ACTIVATED WHOLE BLOOD CLOTTING TIME
• Manufacturer (Section D): ACCRIVA DIAGNOSTICS, INC.; 6260 sequence drive; san diego CA 92121
• Manufacturer (Section G): ACCIVA DIAGNOSTICS, INC.; 6260 sequence drive; san diego 92121
• Manufacturer Contact: wenni haley ; 6260 sequence drive; san diego 92121 ; 8582632322
• MDR Report Key: 20295483
• Report Number: 2250033-2024-00002
• Device Sequence Number: 7171687
• Product Code: JBP
• UDI-Device Identifier: 10711234103067
• UDI-Public: 10711234103067
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K941007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2025

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 Expiration Date: 07/31/2024
• Device Catalogue Number: JACT+
• Device Lot Number: D3JAC095
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/26/2024
• Supplement Date Received by Manufacturer: 03/04/2025
• Initial Report FDA Received Date: 09/24/2024
• Supplement Report FDA Received Date: 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/11/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CLOPIDOGREL
• Outcome Attributed to Adverse Event: Death
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Race: Asian