MAUDE Adverse Event Report: DIAGNOSTICA STAGO STA-R EVOLUTION 115V UL; IVD COAGULATION DEVICE / INSTRUMENT,

Model Number	58978
Medical Device Problem Codes	Incorrect Measurement (1383); Low Test Results (2458)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The service engineer was dispatched to the site 2020-05-20 & 2020-05-21.Found needle 1 partially blocked, instrument files were collected and are being analyzed by the manufacturer.The incident is under investigation and no root cause is yet known.The laboratory used ptt reagent and controls from another manufacturer (i.E.Instrumentation laboratories).
Event or Problem Description
The laboratory observed that several patient samples had resulted low (in the 20's) for the ptt test.The quality control values before these potentially erroneous results were within the established ranges.Qc were not done after the erroneous results; the unit was taken out of service.The samples were rerun on the alternate unit; four samples failed rerun criteria.Four corrected reports were generated.One patient was treated based on the original incorrect result (37 seconds), knowing that this patient had an initial result upon admission of 36 seconds.The patient received a bolus of heparin to get the ptt into the therapeutic range of 60 - 85 seconds.The patient developed a nose bleed.In the meantime the original sample was rerun on their other analyzer and resulted as 51 seconds.The other three patients were not impacted by the erroneous results.
Additional Manufacturer Narrative
The service engineer was dispatched to the site 2020-05-20 & 2020-05-21.Found needle 1 partially blocked, instrument files were collected and are being analyzed by the manufacturer.The incident is under investigation and no root cause is yet known.The laboratory used ptt reagent and controls from another manufacturer (i.E.Instrumentation laboratories).No files attached.Stago reference: (b)(4).Mdr submitted by the manufacturer.Supplemental requested by (b)(4).
Event or Problem Description
The laboratory observed that several patient samples had resulted low (in the 20's) for the ptt test.The quality control values before these potentially erroneous results were within the established ranges.Qc were not done after the erroneous results; the unit was taken out of service.The samples were rerun on the alternate unit; four samples failed rerun criteria.Four corrected reports were generated.One patient was treated based on the original incorrect result (37 seconds), knowing that this patient had an initial result upon admission of 36 seconds.The patient received a bolus of heparin to get the ptt into the therapeutic range of 60 - 85 seconds.The patient developed a nosebleed.In the meantime, the original sample was rerun on their other analyzer and resulted as 51 seconds.The other three patients were not impacted by the erroneous results.
Additional Manufacturer Narrative
The quality controls before the concerned patient's series were within the ranges.The post-run qcs were not tested because the operator decided to stop using the instrument as soon as he detected the issue (customer was alerted by the abnormal shortened ptt results on several samples).The post-run qcs would have probably detected the problem.Our investigation of the instrument files did not identify the root cause of the issue.However, a shortened ptt times could be explained by a potential contamination of the ptt tests by the reagent used in the pt tests.This contamination could be due to a problem with the cleaner rinsing solution.Although not definitive, the customer observed that the problem was resolved once the cleaner container was replaced.Therefore, the most likely root cause was contamination in the cleaner solution.This appears to have been an isolated event.The issue was resolved by replacing the container of cleaner solution.The instrument was checked by a stago engineer; some minor corrections were performed to the mapping and arm movements; however these appear to be unrelated to the observed problem.Stago reference: (b)(4).Mdr submitted by the manufacturer.Supplemental requested by fda _(b)(4).

• Brand Name: STA-R EVOLUTION 115V UL
• Common Device Name: IVD COAGULATION DEVICE / INSTRUMENT,
• Manufacturer (Section D): DIAGNOSTICA STAGO; 3 allée thérésa; asnieres sur seine, 92 92655 ; FR 92655
• Manufacturer Contact: walid ben ammar ; 3 allée thérésa; asnieres sur seine, 92 92655 ; FR 92655
• MDR Report Key: 10407662
• Report Number: 8043723-2020-00004
• Device Sequence Number: 11360468
• Product Code: JPA
• UDI-Device Identifier: 03607450589788
• UDI-Public: (01)03607450589788(11)091224(241)58978
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/26/2025

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: 58978
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/16/2020
• Supplement Date Received by Manufacturer: 07/16/2020; Not provided
• Initial Report FDA Received Date: 08/14/2020
• Supplement Report FDA Received Date: 06/13/2025; 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/24/2009
• Is the Device Labeled for Single Use? (Y/N): No
• 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: Male