MAUDE Adverse Event Report: DIAGNOSTICA STAGO S.A.S. STA COMPACT

Model Number IVD COAGULATION DEVICE/INSTRUMENT

Device Problems False Reading From Device Non-Compliance (1228); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Pleural Effusion (2010); Respiratory Distress (2045)

Event Date 07/14/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).It is alleged by the patient that erroneous pt and inr results by the stago instrumentation may have led to unsuitable therapy followed by surgical/medical intervention to remove fluid in or around the patient's left lung region.This procedure took place on (b)(6) 2015.Diagnostica stago inc.Was not made aware until (b)(6) 2016.Investigation to be determined.

Event Description

Through a legal petition received by diagnostica stago inc.On (b)(6) 2016, the facility became aware of an event that occurred the previous year on or about (b)(6) 2015.A patient at the (b)(6) medical center in (b)(6) alleges that the results generated by the stago instrumentation for pt and inr were erroneous and led to unsuitable therapy which was followed by surgical intervention to remove fluid around the patient's left lung region.

• Brand Name: STA COMPACT
• Type of Device: COMPACT
• Manufacturer (Section D): DIAGNOSTICA STAGO S.A.S.; 125 avenue louis roche; pae parispace 3; gennevilliers, france 92230 ; FR 92230
• Manufacturer (Section G): DIAGNOSTICA STAGO S.A.S.; 125 avenue louis roche; pae parispace 3; gennevilliers, france 92230 ; FR 92230
• Manufacturer Contact: walid ben ammar ; 125 avenue louis roche; pae parispace 3; gennevilliers, france 92230 ; FR 92230 ; 3313072313
• MDR Report Key: 5820444
• MDR Text Key: 50386922
• Report Number: 8043723-2016-00001
• Device Sequence Number: 1
• Product Code: JPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 07/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other Health Care Professional
• Device Model Number: IVD COAGULATION DEVICE/INSTRUMENT
• Device Catalogue Number: 58602
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/11/2016
• Device Age: 12 YR
• Event Location: Hospital
• Date Manufacturer Received: 07/18/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/18/2004
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention