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

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	10/31/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr submitted 12/20/2017 reference accriva diagnostics' complaint (b)(4).The reagent lot number tested with this instrument is e7jac213 is referenced by accriva diagnostics' complaint (b)(4) and is classified as child case of the instrument complaint filed in this submission.(b)(4).Accriva has requested all data required for form fda 3500a.
Event or Problem Description
Healthcare professional reported out of range high readings with a hemochron signature elite and act plus system.A patient with aortic stenosis underwent an aortic valve replacement and was receiving intravenous heparin.The target act was 480 seconds.Act results reported during the procedure were as expected except for a single out-of-range high error.The same sample assayed on a different signature elite instrument reported an act result of 507 seconds and this result was used for patient management.The procedure was completed and no adverse events were reported.
Additional Manufacturer Narrative
This mdr follow-up #2 submitted on 01/24/2018 references accriva diagnostics' complaint number (b)(4), the child complaint that was submitted with parent case (b)(4).This follow-up mdr provides the results of the bioqc evaluation of retained samples for hemochron jr jact+ reagent cuvette.Concomitant medical products: jact+ lot number f7jac213.
Event or Problem Description
Follow-up #2.
Additional Manufacturer Narrative
This mdr follow-up #1 submitted on 01/17/2018 references accriva diagnostic's complaint number (b)(4).This follow-up mdr provides the complaint evaluation summary for the hemochron signature elite instrument (se11367) named in this complaint.This summary was prepared 01/11/2018.The actual device was evaluated.No failure detected.The device passed electronic and liquid quality control testing.Unable to confirm complaint.No failure detected; device operated within specification.
Event or Problem Description
Follow-up #1.

• Brand Name: HEMOCHRON SIGNATURE ELITE WHOLE BLOOD MICROCOAGULATION SYSTEM
• Common Device Name: SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES: JPA
• Manufacturer (Section D): ACCRIVA DIAGNOSTICS; 6260 sequence drive; san diego CA 92121
• MDR Report Key: 7157220
• Report Number: 2250033-2017-00008
• Device Sequence Number: 158301
• 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,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?: Yes
• Date Returned to Manufacturer: 12/27/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/28/2017
• Supplement Date Received by Manufacturer: 12/27/2017; 01/23/2018
• Initial Report FDA Received Date: 01/02/2018
• Supplement Report FDA Received Date: 01/17/2018; 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: 105