MAUDE Adverse Event Report: DIAGNOSTICA STAGO S.A.S. STA-R EVOLUTION; IVD COAGULATION DEVICE/INSTRUMENT

Model Number 58978

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/28/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).On 20mar2019: the manufacturer gave their conclusion to the investigation.The diagnostica stago field support engineer noticed that needle #1 was bent and hitting the edge of the tube/vial, disrupting sampling.Due to contamination the parts replaced (needle #1 and washing well #3) were discarded but pictures were provided.Qc was in before and after the sample run.There was no specific warning to the customer and results were released.The most likely root cause was a combination of failed needle #1 and washing well #3.Since the parts were discarded due to contamination, it is not possible to investigate any further.The manufacturer has concluded their investigation into this matter.

Event Description

On (b)(6) 2019: the diagnostica stago inc.Hotline received a call from the medical college of (b)(6) coag lab stating that erroneous results were produced and released.The results were questioned by the nursing staff and rerun on their other instrument.It produced results matching the previous ones.On (b)(6) 2019: the customer reported that the erroneous results failed delta checks but were released.The affected tests were for pt, ptt, d-dimer, and fibrinogen.The customer also stated that the tests were not rerun as previously stated and were accepted knowing that the delta checks had failed.On (b)(6) 2019: the customer provided information on the stago questionnaire.A total of five patient results were affected and there was no harm or injury to any of the patients.The manufacturer was notified by email about a potential reportable event.This incident is considered a malfunction since qc was in range before and after the event.

• Brand Name: STA-R EVOLUTION
• Type of Device: IVD COAGULATION DEVICE/INSTRUMENT
• Manufacturer (Section D): DIAGNOSTICA STAGO S.A.S.; 3 allée theresa; asnières-sur-seine, 92600 ; FR 92600
• Manufacturer (Section G): DIAGNOSTICA STAGO S.A.S.; 3 allée theresa; asnières-sur-seine, 92600 ; FR 92600
• Manufacturer Contact: walid ben ammar ; 2 rue pierre fossati; franconville val d'oise, 95130 ; FR 95130
• MDR Report Key: 8455816
• MDR Text Key: 144990582
• Report Number: 8043273-2019-00004
• Device Sequence Number: 1
• Product Code: JPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082675
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 03/19/2019,02/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 58978
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/28/2019
• Device Age: 6 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/19/2019
• Date Manufacturer Received: 03/05/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/15/2013
• 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