MAUDE Adverse Event Report: ACCRIVA DIAGNOSTICS HEMOCHRON SIGNATURE ELITE MICROCOAGULATION SYSTEM; 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 12/20/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method codes: actual device not evaluated.Process evaluation performed.Results: no results available since no evaluation performed.Conclusions: device not returned.Accriva diagnostics has requested all data required for form 3500a.The customer refused to return (b)(4) to accriva for evaluation.This is the initial and final form fda 3500a submission.

Event Description

A healthcare professional reported discrepant act results with three different hemochron signature elite and act+ microcoagulation systems during a cardiovascular procedure.The target act was 300-350 seconds.Three hours into the case, act results recorded by the instrument named in this complaint was 260 seconds but repeat samples run on the other 2 instrument recorded discordant act results.The patient was given an iv bolus dose of 3,000 units of heparin and the procedure was completed uneventfully.Both electronic and liquid qc had passed prior to the procedure.No bleeding or other complications were reported.

• Brand Name: HEMOCHRON SIGNATURE ELITE MICROCOAGULATION SYSTEM
• Type of Device: SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES
• Manufacturer (Section D): ACCRIVA DIAGNOSTICS; 6260 sequence drive; san diego CA 92121
• Manufacturer (Section G): ACCRIVA DIAGNOSTICS; 6260 sequence drive; san diego CA 92121
• Manufacturer Contact: jon mcdermed ; 6260 sequence drive; san diego, CA 92121 ; 8582632490
• MDR Report Key: 7281254
• MDR Text Key: 100569764
• Report Number: 2250033-2018-00003
• Device Sequence Number: 1
• Product Code: JPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2018
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Weight: 125