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

Model Number IVD COAGULATION DEVICE/INSTRUMENT

Device Problem Insufficient Information (3190)

Patient Problems Blood Loss (2597); Patient Problem/Medical Problem (2688)

Event Date 07/03/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Stago will provide a follow-up report(s) once relevant information has become available.

Event Description

On (b)(6) 2018: stago hotline received a call from the customer indicating that there were some samples that resulted as

Manufacturer Narrative

Diagnostica stago, inc.Is submitting this report on behalf of diagnostica stago s.A.S.Gennevilliers (manufacturer) under exemption number (b)(4).Stago investigated the event under corporate complaint file (b)(4).(b)(6)2018: additional verbal communication received from the customer indicated that none of the patients mentioned in this incident had any further complications.The customer also stated they switched to using aptt for monitoring and the patients were stabilized.No further patient information has been received.(b)(6)2018: the system dump file was analyzed, but it was not possible to obtain the patients' tubes identification.The kinetics of the curves analyzed appear normal and no errors were observed.The needle was replaced as per customer's request due to 100k cycles being reached and the software was prompting for its replacement.The customer never answered stago's additional questions, despite several documented requests.This case is isolated and this complaint is unverifiable.The data obtained does not allow for an investigation of the complaint that would indicate that there was a true malfunction of the device.Stago is concluding its investigation into this matter.

• Brand Name: STA-R EVOLUTION
• Type of Device: EVOLUTION
• Manufacturer (Section D): DIAGNOSTICA STAGO S.A.S.; 125 avenue louis roche; pae parispace 3; gennevilliers, 92230 ; FR 92230
• MDR Report Key: 7756303
• MDR Text Key: 116212980
• Report Number: 8043723-2018-00002
• Device Sequence Number: 1
• Product Code: JPA
• Combination Product (y/n): N
• PMA/PMN Number: K082675
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 08/03/2018,12/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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: 07/13/2018
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/03/2018
• Date Manufacturer Received: 07/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other