MAUDE Adverse Event Report: DIAGNOSTICA STAGO S.A.S. STA COMPACT MAX; IVD COAGULATION DEVICE/INSTRUMENT

Model Number 58990

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/12/2019

Event Type  Injury  

Event Description

A lab technician manually entered an incorrect result for a patient: 20.0 ¿g/ml instead of 0.37¿g/ml.The technician confused the end part of the name of the assay "lia-test ddi 20 ¿g/ml" as the result.Customer acknowledged there was nothing wrong with the analyzer.Instructions were given to customer to change the name of the test, to avoid confusion.Based upon the reported result the patient received a ct angiogram.This did not result in any injury, impairment, or death to the patient.

• Brand Name: STA COMPACT MAX
• Type of Device: IVD COAGULATION DEVICE/INSTRUMENT
• Manufacturer (Section D): DIAGNOSTICA STAGO S.A.S.; 3 allee theresa; asnieres-sur-seine, 92600 ; FR 92600
• MDR Report Key: 9046001
• MDR Text Key: 159128723
• Report Number: 8043723-2019-00008
• Device Sequence Number: 1
• Product Code: JPA
• UDI-Device Identifier: 03607450589900
• UDI-Public: (01)03607450589900(11)140122(241)58990
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 09/04/2019,08/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 58990
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/13/2019
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other