MAUDE Adverse Event Report: ACCRIVA DIAGNOSTICS HEMOCHRON SIGNATURE ELITE WHOLE BLOOD 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 05/09/2018

Event Type  malfunction  

Manufacturer Narrative

This mdr references accriva diagnostics' complaint number (b)(4) for the hemochron signature elite instrument, serial number (b)(4).Complaint number (b)(4) captures the child case for the lot number of the jact+ cuvette used during the procedure.(b)(4) actual device not evaluated.Process evaluation performed.Dhf review shows no history of service or repairs no results available since no evaluation performed.Conclusion not yet available - evaluation is in progress.Accriva diagnostics has requested all data required for form 3500a.Fields for which data were not obtainable or are not applicable are intentionally left blank.

Event Description

A healthcare professional reported discrepant act results with a hemochron signature elite and act+ whole blood microcoagulation system during an ablation procedure for an abnormal heart rhythm.The target act for this procedure was 350 to 400 seconds.The third act reading was 278 seconds, which was a lower than expected result.A repeat blood sample was drawn and tested on a different elite instrument.The act reading was 352 seconds, which was within the expected range.The repeat act result of 352 seconds was used for patient management.The procedure was completed successfully and no bleeding or other medical complications were reported.Both electronic and liquid quality controls passed prior to the procedure.

Event Description

Follow-up #1.

Manufacturer Narrative

Mdr 2250033-2018-00015 follow-up #1 provides the results of the instrument evaluation for the hemochron signature elite instrument, serial number (b)(4) named in accriva diagnostics' complaint number (b)(4).Method code: 10 actual device was evaluated.Results code: 213 no failure detected.Whole blood liquid qc was assayed and results were found to be within specification and close to the mean; electronic qc passed as well.Conclusion code: 67 unable to confirm complaint.

• Brand Name: HEMOCHRON SIGNATURE ELITE WHOLE BLOOD MICROCOAGULATION SYSTEM
• 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: 7612282
• MDR Text Key: 111448561
• Report Number: 2250033-2018-00015
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 06/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2018
• 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: 05/22/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COUMADIN, UNKNOWN DOSAGE; HEMOCHRON JR ACT+ CUVETTE, LOT M7JAC798
• Patient Age: 72 YR
• Patient Weight: 79