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

Model Number ELITE

Device Problem High Test Results (2457)

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

Event Date 11/09/2017

Event Type  malfunction  

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 (b)(4) and is referenced by accriva diagnostics' complaint number (b)(4).Method codes: actual device not evaluated.Process evaluation was performed.Dhr reviewed showed no ncrs, capas, instrument repairs or other anomalies related to this complaint.Results code: no results available since no evaluation performed.Conclusion code: conclusion not yet available - evaluation in progress.Accriva has requested all data required for form fda 3500a.

Event Description

Healthcare professional reported an out of range high reading with a hemochron signature elite and act plus system.A patient with mitral insufficiency underwent a mitral valve repair 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 an act result of 549 seconds was reported.This result was used for patient management.The procedure was completed withour incident and no adverse events were reported.

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.Concomitant products: jact+ lot number f7jac213.

Event Description

Follow-up #1.

• Brand Name: HEMOCHRON SIGNATURE ELITE
• Type of Device: MULTIPURPOSE SYSTEM FOR IN VITRO COAGULATION STUDIES
• Manufacturer (Section D): ACCRIVA DIAGNOSTICS; 6260 sequence drive; san diego CA 92121
• MDR Report Key: 7170027
• MDR Text Key: 97475424
• Report Number: 2250033-2018-00002
• Device Sequence Number: 1
• Product Code: JPA
• UDI-Device Identifier: 10711234510018
• UDI-Public: 10711234510018
• Combination Product (y/n): N
• PMA/PMN Number: K050016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2018
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HEMOCHRON JR ACT+ CUVETTE; JACT+ CUVETTE LOT F7JAC213
• Patient Age: 54 YR
• Patient Weight: 76