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

Model Number	ELITE
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr references accriva diagnostics' complaint number (b)(4) for hemochron signature elite serial number (b)(4).A child case capturing the reagent and lot number of the disposable device tested with this instrument is f7jac213 and is referenced by accriva diagnostics' complaint number (b)(4).Accriva has requested all data required for form fda 3500a.
Event or Problem Description
Healthcare professional reported an out of range high reading with a hemochron signature elite and act plus system.A patient with coronary artery disease underwent an four-vessel coronary artery bypass and was receiving intravenous heparin.The target act was 480 seconds.Act results measured during the procedure were as expected except for a single out-of-range high error.The same sample was assayed on a different signature elite instrument and reported an act result of 687 seconds and this result was used for patient management.The procedure was completed without incident and no adverse events were reported.
Additional Manufacturer Narrative
This mdr follow-up #1 submitted on 01/24/2018 references accriva diagnostics' parent complaint number (b)(4) and the child complaint (b)(4) that was submitted with the parent complaint.This follow-up mdr provides the results of (1) device evaluation of signature elite instrument, serial number (b)(4) alleged in the parent complaint and (2) the bioqc evaluation of retained samples of hemochron jr jact+ reagent cuvette used in the procedure.The actual device (b)(4) was evaluated; a jact+ device from same lot evaluated; process evaluation performed.A dhr review was performed for each device.No ncr or previous repairs related to the complaint were identified for the signature elite instrument.No ncr or any other anomalies related to the complaint were identified for the jact+ cuvette.No failure detected.No failure detected; both devices operated within specification.Correction: concomitant medical products: jact+ lot number f7jac213.
Event or Problem Description
Follow-up #1.

• Brand Name: HEMOCHRON SIGNATURE ELITE
• Common Device Name: SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES
• Manufacturer (Section D): ACCRIVA DIAGNOSTICS; 6260 sequence drive; san diego CA 92121
• MDR Report Key: 7170036
• Report Number: 2250033-2018-00001
• Device Sequence Number: 19362142
• Product Code: JPA
• UDI-Device Identifier: 10711234510018
• UDI-Public: 10711234510018
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K050016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ELITE
• Device Catalogue Number: ELITE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/12/2017
• Supplement Date Received by Manufacturer: 01/23/2018
• Initial Report FDA Received Date: 01/05/2018
• Supplement Report FDA Received Date: 01/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 83