MAUDE Adverse Event Report: DIAGNOSTICA STAGO STA COMPACT MAX; IVD Coagulation Device/Instrument

Model Number	58989
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A local intervention performed on april 30, 2026, led to the replacement of several spare parts.Some removed components are returning to stago france for further analysis, and additional data investigations are currently ongoing.A follow-up report will be provided as soon as the investigation is completed.Stago reference file: (b)(4) this report is submitted by the manufacturer.
Event or Problem Description
On (b)(6) 2026, on sta compact max sn (b)(6), pt = 78.9 s, 10.1 (inr), ptt = 81.7s / fib = 142mg/dl has been produced for patient sid (b)(6).Reran on the same instrument : pt = 28.4s/2.7 (inr) / fib = 135mg/dl then reran on another instrument (sta compact max sn (b)(6)): pt = 29.3s/2.80 (inr) ptt = 56.4s / fib = 165 mg/dl.On (b)(6) 2026, on the same instrument, two other patients were affected by erroneous results on sta compact max sn (b)(6): - sid (b)(6) with pt = 116.6s, 16.81 (inr)/ ptt = 33.5s/ fib = 332mg/dl.Reran on the same instrument : pt = 26.4s, 2.43(inr) / ptt = 37.3s / fib = 304 mg/dl then reran on another instrument (sta compact max sn (b)(6)): pt = 19.6s, 1.66 (inr) / ptt = 35 s / fib = 402 mg/dl.- sid (b)(6) with pt = 42.0s, 4.45(inr).Reran on the same instrument : pt = 35.0s, 3.52 (inr) then reran on another instrument (sta compact max sn (b)(6)): pt = 35.6s, 3.59 (inr).The erroneous results produced on sta compact max sn (b)(6) were not released.Only repeated results on sta compact max (b)(6) were reported.No change in treatment was observed.On april 17, 2026, the manufacturer's review of instrument data files revealed inconsistent and inaccurate pipetting of samples and reagents for the affected samples, suggesting a potential instrument malfunction.A single mdr is submitted for 3 affected samples, tested on not consecutive days, but all associated with the same potential instrument malfunction.

• Brand Name: STA COMPACT MAX
• Common Device Name: IVD Coagulation Device/Instrument
• Manufacturer (Section D): DIAGNOSTICA STAGO; 3 allée thérésa; asnieres sur seine, 92600 ; FR 92600
• Manufacturer Contact: walid ben ammar ; 3 allée thérésa; asnieres sur seine, 92 92600 ; FR 92600
• MDR Report Key: 25162450
• Report Number: 8043723-2026-00002
• Device Sequence Number: 13446201
• Product Code: JPA
• UDI-Device Identifier: 03607450589894
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2026

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?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2026
• Supplement Date Received by Manufacturer: 04/07/2026
• Initial Report FDA Received Date: 05/13/2026
• Supplement Report FDA Received Date: 08/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2016
• 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