MAUDE Adverse Event Report: ACCRIVA DIAGNOSTICS HEMOCHRON SIGNATURE ELITE; SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES

Model Number ELITE

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/09/2018

Event Type  malfunction  

Manufacturer Narrative

This mdr references accriva diagnostics' complaint (b)(4) for the hemochron signature elite instrument, serial (b)(4).(b)(4) references the disposable hemochron jr.Act-lr device (lot number j7jlr194) that used during the procedure and is submitted together in this initial, 30-day mdr.Accriva diagnostics has requested all data required for form 3500a.F an instrument evaluation is anticipated.Results of the evaluation will be submitted as mdr 2250033-2018-00009 follow-up #1.

Event Description

Healthcare professional working in a hospital in (b)(6) reported that two hemochron signature elite and act low-range assay systems reported inconsistent act results when the meters were run side-to-side during a pci and stent placement procedure.The patient was receiving intermittent doses of intravenous heparin with a target act range of 300-350 seconds.The same lot number of hemochron jr act-lr cuvettes (j7jlr194) was used on both meters throughout the procedure.One blood sample generated a pair of act results that differed significantly from one another.The act result assayed on the elite named in this complaint ((b)(4)) was 254 seconds, which was lower than the target act.The act result on the second elite ((b)(4)) was 321 seconds, which was an expected result.The act result of 321 seconds was used for patient management.No bleeding, thrombosis or other medical complications were reported.Both hemochron signature elite instruments passed electronic qc before the procedure.Act-lr readings with liquid qc (normal and abnormal levels) were within their acceptable ranges when run on both instruments.

Event Description

Follow-up #1.

Manufacturer Narrative

This follow-up mdr #1 references accriva diagnostics' complaint number (b)(4) and reports the results of an evaluation of the jact-lr reagent cuvette included as the child case (b)(4) in the parent case (b)(4).Test performance of the reagent cuvette was evaluated on 05/29/2018.Device from same lot evaluated (j7jlr194, date of manufacture, 09/22/2017, expiry date 12/31/2018, udi (b)(4)).No failure detected when the device was tested with liquid qc and whole blood samples.Unable to confirm complaint.The distributor of the elite-int (se10079) named as the parent in the initial mdr refused to return the device to accriva.However, the distributor evaluated the device and stated that the device operated within specification.None of the data that was unavailable to accriva at the time of the initial mdr was submitted materialized.

• Brand Name: HEMOCHRON SIGNATURE ELITE
• Type of Device: SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES
• Manufacturer (Section D): ACCRIVA DIAGNOSTICS; 6260 sequence drive; san diego CA 92121
• MDR Report Key: 7431417
• MDR Text Key: 105918705
• Report Number: 2250033-2018-00009
• Device Sequence Number: 1
• Product Code: JPA
• Combination Product (y/n): N
• PMA/PMN Number: K050016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 05/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ELITE
• Device Catalogue Number: ELITE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 85 YR
• Patient Weight: 70