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

Model Number	58989
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On (b)(6) 2021, a service engineer (fse) was dispatched to the customer for evaluation/repair.Several actions were done : vacuum adjustment, and a change of syringe, washwell, and tube z3.The fse also found cuvette balls lying around.On (b)(6) 2021, the fse was dispatched again; the fse changed the cap piercing needle, the pinch valve, the piercing mechanism, and the block of 3 electrovalves.The instrument data files have been collected and the analysis is ongoing.A follow-up report will be sent once the investigation is complete.The stago reference complaint is (b)(4).
Event or Problem Description
Four erroneous ufh results with sta liquid anti-xa reagent on sta compact max analyzer were reported.All of them were falsely <0.1 iu / ml results (absence of heparin).On (b)(6) 2021 : results <0.1 iu / ml.Then, tests reran the same day on another instrument: patient 1: released at 0.51 iu / ml.Patient 2: released at 1.11 iu / ml.Patients 1 & 2 have received a change in the therapy but no serious injury was reported.On (b)(6) 2021: results <0.1 iu / ml.Then, tests reran 30min later on the same instrument: patient 3: released at 0.33 iu / ml.Patient 4: released at 0.21 iu / ml.No information about any changes in treatment for these patients.No serious injury to our knowledge.The internal quality controls were within acceptable ranges before and after the events.
Additional Manufacturer Narrative
The instrument data files were analyzed by our r&d department.They have checked the pipetting heights on the concerned patient's sample tube (with erroneous results released) and confirmed that the level detections occurred too high, before reaching the tube (just above the cap).These level detection resulted in pipetting in the air which is consistent with the wrong <0.1 ui/ml results.The field support engineer's interventions on 8 and 10 december 2021 resulted in the changing of several spare parts, however there is no evident relationship between this random issue and the spare parts changed.Conclusion: the instrument file analysis and local intervention did not lead to a conclusive determination of the root cause of this random and rare level detection error.Stago has concluded its investigation into this matter and considers it as confirmed and isolated, and plans no further action in this matter.Stago reference : (b)(4).Supplemental requested by fda _(b)(4).

• Brand Name: STA COMPACT MAX
• Common Device Name: IVD COAGULATION DEVICE/INSTRUMENT
• Manufacturer (Section D): DIAGNOSTICA STAGO S.A.S.; 3 allée thérésa; asnières-sur-seine, 92600 ; FR 92600
• Manufacturer Contact: walid ben ammar ; 3 allée thérésa; asnières-sur-seine, 92600 95130 ; FR 95130
• MDR Report Key: 13073476
• Report Number: 8043723-2021-00001
• Device Sequence Number: 17615725
• Product Code: JPA
• UDI-Device Identifier: 03607450589894
• UDI-Public: (01)03607450589894(11)171130(241)58989
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 58989
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/30/2021
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/23/2021
• Supplement Report FDA Received Date: 06/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/30/2017
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown