MAUDE Adverse Event Report: DIAGNOSTICA STAGO STA SATELLITE; IVD COAGULATION DEVICE/INSTRUMENT

Model Number	58104
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigations are on going under corporate complaint (b)(4).Stago will provide a follow-up report(s) once relevant information has become available.
Event or Problem Description
On (b)(6) 2020, customer released an inr greater than 16.0 following two repeated vmax error on the pt test.According to the customer, quality control before and after the results were in range.Customer performed the maintenance of the instrument and repeated again the test: inr= 2.4.The corrected result was called to provider: no change made to patient therapy due to the initial result.Then on (b)(6) 2020, qc for pt and ptt were in vmax error.Qc repeated within range but after a third run, ptt qc were in vmax again.Instrument taken out of service and samples frozen.A technical intervention has been asked and performed the same day: the technician found a needle clogged and replaced needle from customer inventory.Preliminary conclusion: the most likely root cause was a clogged needle.
Additional Manufacturer Narrative
The instrument data files were analyzed: quality controls (qc) were in range before and after the samples in question were run.Two of the three concerned samples registered a tmax error (technical error) which likely were associated with cuvette errors.Following this error series, the analyzer was restarted by the customer.A cuvette roll error was also detected during the instrument initialization.It appears that the customer changed the cuvette roll in an attempt to resolve this issue.During the service intervention, the only anomaly found by the stago engineer was a clogged needle (which was replaced).Analysis: it appears that there is a connection between cuvette errors and erroneous results, however this hypothesis is not likely to have been caused by a clogged needle.Conclusion: therefore, the true root cause could not be definitively determined.Stago has concluded its investigation into this matter and considers it as confirmed and isolated, with no further action.Supplemental requested by (b)(4).

• Brand Name: STA SATELLITE
• Common Device Name: IVD COAGULATION DEVICE/INSTRUMENT
• Manufacturer (Section D): DIAGNOSTICA STAGO; 2 rue pierre fossati; franconville, 95130 ; FR 95130
• Manufacturer Contact: walid ben ammar ; 2 rue pierre fossati; franconville, 95130 ; FR 95130
• MDR Report Key: 10024815
• Report Number: 8043723-2020-00003
• Device Sequence Number: 19511777
• Product Code: JPA
• UDI-Device Identifier: 03607450581041
• UDI-Public: (01)03607450581041(11)180406(241)58104
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K082248
• 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: Administrator/Supervisor
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2020

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
• Operator of Device: Health Professional
• Device Model Number: 58104
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/06/2020
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/05/2020
• Supplement Report FDA Received Date: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2018
• 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: Unknown