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

Model Number	ELITE
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Method: analysis of production records.No history of service, repairs, capas or ncs.No complaints related to the one stated in the current report.Results: no findings available.Conclusion: conclusion not yet available.Accriva diagnostics has requested all data required for form 3500a.This is the initial 30-day report that precedes the instrument evaluation.Mdr 2250033-2018-00031 follow-up #1 will be submitted after the device is returned to the manufacturer and the evaluation is completed.
Event or Problem Description
Healthcare professional reported that a hemochron signature elite and low-range act system reported lower than expected act results during an ablation treatment for atrial fibrillation.The patient received an intravenous bolus dose of heparin with an act target of 300 seconds.The first blood sample generated an act result that was as expected.The next 4 act readings were lower than the target range while additional heparin was given.A fifth blood sample was drawn and assayed on a second hemochron signature elite instrument using the same lot of hemochron act-lr cuvettes.This generated an act result >300 seconds, which was an expected result.The second signature elite instrument was used for further act testing.All act results were >300 seconds and were used for patient management.No adverse events or medical complications were reported.The hemochron signature elite and low-range act system passed electronic and liquid qc before the procedure.
Additional Manufacturer Narrative
This follow-up mdr number 2250033-2018-00031 #1 references accriva diagnostics' complaint number (b)(4) and provides the results of the complaint evaluation summary for the hemochron signature elite, serial number (b)(4).Method code: 10 testing of actual device.Results code: 213 no device problem found.Conclusion code: 67 no problem detected.No additional data requested from the customer that is required to complete form fda 3500-a has been received since the initial mdr was submitted.Thye root cause for the lower tan expected patient result could not be determined.Mdr 2250033-2018-00031 follow-up #1 is accriva diagnostics' final report on this complaint and effectively closes the case.
Event or Problem Description
Follow-up #1.

• Brand Name: HEMOCHRON SIGNATURE ELITE MICROCOAGULATION SYSTEM
• 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: 8201757
• Report Number: 2250033-2018-00031
• Device Sequence Number: 2056487
• Product Code: JPA
• UDI-Device Identifier: 10711234510018
• UDI-Public: 10711234510018
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 12/11/2018

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: 01/02/2019
• Initial Date Received by Manufacturer: 12/11/2018
• Supplement Date Received by Manufacturer: 12/11/2018
• Initial Report FDA Received Date: 12/27/2018
• Supplement Report FDA Received Date: 02/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 122