MAUDE Adverse Event Report: ACCRIVA DIAGNOSTICS HEMOCHRON SIGNATURE ELITE; SYSTEM, IN-VITRO MICROCOAGULATION

Model Number	ELITE
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/01/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr submitted 09/30/2016 references accriva diagnostics' complaint number (b)(4).This initial report is submitted prior to availability of all required data and before the device could be evaluated.Actual device not evaluated.Process evaluation was performed.Dhr reviewed showed no ncrs, capas, instrument repairs or other anomalies related to this complaint.Results: no results available since no evaluation performed.Conclusion: device not returned.Accriva has requested all data required for form fda 3500a.
Event or Problem Description
Healthcare professional reported discrepant act results using a hemochron signature elite and act-lr system during a cardiovascular procedure.The target act range was 250 to 300 seconds.After iv heparin was given, a series of whole blood samples were assayed for act measurements.The fourth act result was 387 seconds, which was a result that was higher than expected.Another blood sample was drawn a few minutes later and was assayed on a second hemochron signature elite instrument using the same reagent lot (f6jlr176).The act reading was reported as 236 seconds, which was a result that was to be expected.The case was managed using the second elite and act+ system.No adverse effects were reported.Electronic and liquid quality controls consistently passed on both elite instruments.The procedure for whole blood collection by the user and storage of the reagent cuvettes were reviewed and found to be consistent with labeled instructions.
Additional Manufacturer Narrative
This mdr follow-up #1 submitted 10/13/2016.(b)(4).Method: the actual device was evaluated.Results: no failure detected.The device passed electronic and liquid quality control testing.Conclusion: unable to confirm complaint.No failure detected, device operated within specification.(b)(4).
Event or Problem Description
Follow-up #1.

• Brand Name: HEMOCHRON SIGNATURE ELITE
• Common Device Name: SYSTEM, IN-VITRO MICROCOAGULATION
• Manufacturer (Section D): ACCRIVA DIAGNOSTICS; 6260 sequence drive; san diego CA 92121
• MDR Report Key: 5992158
• Report Number: 3002721930-2016-00012
• Device Sequence Number: 19311933
• Product Code: JPA
• UDI-Device Identifier: 10711234530252
• UDI-Public: 10711234530252
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 10/13/2016

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: 09/30/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/01/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/30/2016
• Supplement Report FDA Received Date: 10/13/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 77