MAUDE Adverse Event Report: ACCRIVA DIAGNOSTICS, INC. HEMOCHRON ACT-LR TEST; ACTIVATED WHOLE BLOOD CLOTTING TIME

Model Number	JACT-LR
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Coagulation Disorder (1779)
Date of Event	04/15/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
This mdr references accriva diagnostics' complaint number (b)(4) for the hemochron jact-lr cuvette lot k1jlr265.Hemochron signature elite instrument (b)(4) was used during the procedure.The cuvette has a labeled expiration date of 01/31/2023.Historical data analysis and analysis of production records did not provide any information relevant to this complaint.Retain samples of the same lot of the device were tested and performed within expectations.Communication / interviews were conducted with healthcare professionals involved in the catheterization procedure.None of their responses indicated a connection between the performance of the jact-lr cuvette or the hemochron signature elite instrument and the death of the patient.Complaint alleged to the device were investigated by testing retain samples of the same device and the same lot.The investigation found no device problem and concluded no problem was detected.Accriva diagnostics has requested all data required for form 3500a.
Event or Problem Description
(b)(6) male with advanced cirrhosis of the liver was undergoing a diagnostic cardiac catheterization and coronary artery stent placement prior to a scheduled liver transplant.A 7,000 unit bolus dose of heparin was administered before the procedure began.The target act target range was >250 seconds.Fifteen minutes later the initial act reading was out of range low.An 8,000 unit bolus of heparin was administered and the second act reading 4 minutes later was out of range high.No further act testing was done and the procedure was completed.Following the procedure, the patient had low platelet count, prolonged pt/inr and low hematocrit.Blood products were transfused, after which the patient passed away.All healthcare professionals involved in the procedure were interviewed.The investigation concluded that death of the patient was not related to device performance issues with the hemochron signature elite analyzer or low-range act test device.The results of quality controls were also reviewed.Qc results from both electronic and liquid quality controls demonstrated passing results.

• Brand Name: HEMOCHRON ACT-LR 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): ACCRIVA DIAGNOSTICS, INC.; 6260 sequence drive; san diego CA 92121
• Manufacturer Contact: jon mcdermed ; 6260 sequence drive; san diego, CA 92121 ; 8582632490
• MDR Report Key: 14473391
• Report Number: 0002250033-2022-00001
• Device Sequence Number: 14627583
• Product Code: JBP
• UDI-Device Identifier: 10711234103081
• UDI-Public: 10711234103081
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K960749
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/18/2022

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: 01/31/2023
• Device Model Number: JACT-LR
• Device Catalogue Number: JACT-LR
• Device Lot Number: K1JLR265
• 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: 04/18/2022
• Initial Report FDA Received Date: 05/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2021
• 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: HEMOCHRON SIGNATURE ELITE, SERIAL NUMBER (B)(4)
• Outcome Attributed to Adverse Event: Death
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 84 KG