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

Model Number	ELITE
Medical Device Problem Codes	High Test Results (2457); Low Test Results (2458)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Missing Value Reason (3192)
Date of Event	10/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr references accriva diagnostics complaint number (b)(4).The child case (b)(6) references the jact+ lot that was used in the procedure.Method code: actual device not evaluated, process evaluation performed, results code: no results available since no evaluation performed, result are pending completion of evaluation.Conclusion code: conclusion not yet avalaible evaluation is in progress.Accriva diagnostics has requested all data required for form 3500a.
Event or Problem Description
Healthcare professional reported unexpectedly low act result using a hemochron signature elite and act+ system during a cardiovascular procedure.The target act range was 250 to 350 seconds.After 9000 units of heparin was given, a whole blood sample was assayed and the act+ result was 412 seconds.A subsequent act+ result was 158 seconds which was unexpectedly low.No complications occured during the procedure.Prior to the procedure, the instrument involved successfully passed both electrical and liquid quality control tests.No other medical complications were reported.
Additional Manufacturer Narrative
This mdr follow-up #1 references accriva diagnostics' complaint number (b)(4) for hemochron signature elite serial number (b)(4).This provides results of the complaint evaluation summaryt dated 01/05/2018.Method code: the actual device was evaluated.Results code: no failure detected.The device passed electronic quality control.The device also passed liquid quality control testing - act results with level 1 and level 2 controls were nearly identical when assayed with retained samples from the same lot of act+ test devices used.Conclusion codes: unable to confirm complaint.No failure detected; device operated within specification.
Event or Problem Description
Follow-up #1.

• Brand Name: HEMOCHRON SIGNATURE ELITE
• 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: 7067867
• Report Number: 2250033-2017-00007
• Device Sequence Number: 156652
• Product Code: JPA
• UDI-Device Identifier: 10711234510018
• UDI-Public: 10711234510018
• Combination Product (Y/N): N
• Initial Reporter State: WY
• 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): 01/10/2018

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: 11/28/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/08/2017
• Supplement Date Received by Manufacturer: 01/08/2018
• Initial Report FDA Received Date: 11/29/2017
• Supplement Report FDA Received Date: 01/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 121