MAUDE Adverse Event Report: ACCRIVA DIAGNOSTICS, INC. HEMOCHRON WHOLE BLOOD MICROCOAGULATION SYSTEM; SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES

Model Number	ELITE
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Myocardial Infarction (1969)
Date of Event	02/28/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
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.
Additional Manufacturer Narrative
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.

• Brand Name: HEMOCHRON WHOLE BLOOD MICROCOAGULATION SYSTEM
• Common Device Name: SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES
• 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: angela yu ; 6260 sequence drive; san diego, CA 92121 ; 8582632309
• MDR Report Key: 18984075
• Report Number: 2250033-2024-00001
• Device Sequence Number: 14170167
• Product Code: JPA
• UDI-Device Identifier: 10711234510018
• UDI-Public: 10711234510018
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/26/2024

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/30/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: HEPARIN 500U @ 0853, 1000U @0906, 3000U @1008.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Patient Weight: 84 KG