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	High Test Results (2457)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Missing Value Reason (3192)
Date of Event	06/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr references accriva diagnostics' complaint number (b)(4) for the hemochron signature elite, serial number (b)(4), the parent case.This mdr also captures a child complaint (b)(4) for the hemochron jr act-lr (low-range) reagent cuvette used.Method codes: analysis of production records.No history of service or repairs.Results code: no findings available.Conclusion code: 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 follow-up #1 will be submitted if the device is returned to the manufacturer for evaluation.
Event or Problem Description
Healthcare professional reported that a hemochron signature elite and low-range act system reported higher than expected act results during a pci procedure and coronary stent placement.The patient was receiving intravenous heparin with a target act of >250 seconds.One blood sample generated an act result that was 173 seconds, which was a lower than expected result.A bolus dose of heparin was given and another blood sample drawn 9 minutes later generated an act result of 344 seconds, which was a higher than expected result.The heparin infusion was discontinued and a repeat blood sample drawn 38 minutes later was 161 seconds.This result was used for patient management and heparin administration was resumed.The hemochron signature elite and low-range act system passed electronic and liquid qc before the procedure.No bleeding was reported during the procedure.
Event or Problem Description
Follow-up #1.
Additional Manufacturer Narrative
Mdr 2250033-2018-00018 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 with retains of the same cuvette lot used in the procedure and results were found to be within specifications, and close to the mean.Electronic qc passed as well.Conclusion code: 67 unable to confirm complaint.

• 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: 7701019
• Report Number: 2250033-2018-00018
• Device Sequence Number: 16461098
• Product Code: JPA
• UDI-Device Identifier: 10711234510018
• UDI-Public: 10711234510018
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 08/09/2018

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: 07/24/2018
• Initial Date Received by Manufacturer: 06/21/2018
• Supplement Date Received by Manufacturer: 07/24/2018
• Initial Report FDA Received Date: 07/18/2018
• Supplement Report FDA Received Date: 08/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ASPIRIN 81 MG DAILY
• Patient Age: 65 YR
• Patient Weight: 82