MAUDE Adverse Event Report: DIAGNOSTICA STAGO S.A.S. STA-R EVOLUTION

Model Number	IVD COAGULATION DEVICE/INSTRUMENT
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pulmonary Embolism (1498); Death (1802)
Date of Event	07/13/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
Diagnostica stago, inc.Is submitting this report on behalf of diagnostica stago, s.A.S.Gennevilliers (manufacturer) under exemption number e2012018.H3 other text : evaluation performed by the distributor.
Event or Problem Description
On (b)(6) 2017, diagnostica stago inc.Became aware of a death at (b)(6).The female patient expired on or about (b)(6) 2017.The patient's pt, ptt, and d-dimer were tested using the stago analyzer [sta-r evolution, serial number (b)(4)].At this time there is no evidence of an instrument malfunction, nor is there a clear connection between the patient's death and the stago testing.The investigation is continuing; full details and additional data are still being received by the designated complaint handling unit.A supplementary/ follow-up report (or reports) will be submitted as pertinent information becomes available.The investigation file is being documented under reference number (b)(4).
Additional Manufacturer Narrative
Diagnostica stago, inc.Is submitting this report on behalf of diagnostica stago, s.A.S.Gennevilliers (manufacturer) under exemption number e2012018.Please refer to (mdr follow-up report 1 - september 21 2017) for information regarding follow-up #1.

• Brand Name: STA-R EVOLUTION
• Common Device Name: EVOLUTION
• Manufacturer (Section D): DIAGNOSTICA STAGO S.A.S.; 125 avenue louis roche; pae parispace 3; gennevilliers, 92230 ; FR 92230
• MDR Report Key: 6785114
• Report Number: 8043723-2017-00002
• Device Sequence Number: 19143962
• Product Code: JPA
• UDI-Device Identifier: 03607450589788
• UDI-Public: (01)03607450589788(11)110106(241)58978
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K082675
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Medical Technologist
• Device Model Number: IVD COAGULATION DEVICE/INSTRUMENT
• Device Catalogue Number: 58978
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/17/2017
• Device Age: 6 YR
• Event Location: Hospital
• Initial Date Received by Manufacturer: 08/07/2017
• Supplement Date Received by Manufacturer: 08/07/2017
• Initial Report FDA Received Date: 08/10/2017
• Supplement Report FDA Received Date: 09/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 75 YR