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

Model Number	IVD COAGULATION DEVICE/INSTRUMENT
Medical Device Problem Code	Incorrect Or Inadequate Test Results (2456)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Diagnostica stago, inc.Is submitting this report on behalf of diagnostica stago, s.A.S.Gennevilliers (manufacturer) under exemption number e2012018.
Event or Problem Description
On (b)(6) 2017, the account called the diagnostica stago hotline to report three erroneous results.Among these three results, only the two following have been detailed: sample 1 ((b)(6) 2017): original results: pt = 31.6 sec with inr = 3.11; repeated: pt = 12.9 sec with inr = 1.1.Sample 2 ((b)(6) 2017): original results: aptt = 37.6 sec; repeated: aptt = 26.8 sec.The customer questioned the results and reran the samples on another stago instrument.The results were then as the customer expected.The quality control (qc) results before and after the erroneous results were found within the defined range.On (b)(6) 2017 the account clarified to the hotline that the two concerned patients had their reports amended.The account stated in writing that patients were not treated and therefore uninjured.The same day, the fse arrived on site and noticed that the needle was sometimes hitting the tube caps.Upon checking the mapping, arm #1 stopped working.To resolve the issue, the fse replaced the x, y, and z motors, both arm circuit boards, and the main rack multifunction circuit board.The system was restored to stago specifications that day.It is important to note that the engineer measured some power deficiencies with the outlet to which the analyzer was attached, and connected the analyzer to a different outlet.As per procedure, certain replaced parts were returned to stago headquarters for evaluation.Although a true root cause could not be determined by diagnostica stago (b)(4) (manufacturer), two hypothesis have been made: power fluctuations at the customer's site have made one of the arm circuit boards (pcb 4 axis) deficient.Arm 1 hit randomly the tube caps due to incorrect system mapping.In both cases, it was a local and temporary issue.As of today, diagnostica stago has concluded its investigation into this matter.

• 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: 6621426
• Report Number: 8043723-2017-00001
• Device Sequence Number: 16299859
• Product Code: JPA
• UDI-Device Identifier: 03607450589788
• UDI-Public: (01)03607450589788(11)140313(241)58978
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Medical Technologist
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 02/24/2017
• Report Date (Section F): 06/08/2017

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: 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: 02/24/2017
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/08/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2017
• Initial Report FDA Received Date: 06/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 06/08/2017