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

Model Number	58990
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2019
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional Manufacturer Narrative
A lab technician released a false result for a patient.Ddimer testing : 20.0 g/ml instead of 0.37 g/ml.Root cause identified : the lab technician misinterpreted the name of the assay, named by the lab,"lia-test ddi 20 g/ml" with the patient result.Customer acknowledged there is nothing wrong with the analyzer and that was a lab technician mistake.Instructions were given to customer to change the name of the test, without units to avoid any future misinterpretation.This case is considered as an isolated case.No complementary action.

• Brand Name: STA COMPACT MAX
• Common Device Name: IVD COAGULATION DEVICE/INSTRUMENT
• Manufacturer (Section D): DIAGNOSTICA STAGO S.A.S.; 3 allee theresa; asnieres-sur-seine, 92600 ; FR 92600
• Manufacturer Contact: walid ben ammar ; 3 allée thérésa; asnieres sur seine, 92600 ; FR 92600
• MDR Report Key: 9046001
• Report Number: 8043723-2019-00008
• Device Sequence Number: 2537717
• Product Code: JPA
• UDI-Device Identifier: 03607450589900
• UDI-Public: (01)03607450589900(11)140122(241)58990
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K130090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2025
• Report Date (Section F): 09/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 08/13/2019
• Initial Report FDA Received Date: 09/13/2019
• Supplement Report FDA Received Date: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/22/2014
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown