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

Model Number	58989
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023, the instrument produced critical heparin (ufh) results for 4 patients :ufh = 0.00 ui/ml.When samples were reran, the results were as follow: a.Initial result: <0.10, corrected: 0.49 drawn date/time: original: (b)(6) 2023 @ 06:31 corrected: 10:00; b.Initial result: <0.10, corrected: 0.82 drawn date/time: original: (b)(6) 2023 @ 06:05 corrected: 09:29; c.Initial result: <0.10, corrected: 0.17 drawn date/time: original: (b)(6) 2023 @ 07:22 corrected: 09:36; d.Initial result: <0.10, corrected: 0.68 drawn date/time: original: (b)(6) 2023 @ 07:22 corrected: 09:39.Samples were uncapped.According to the customer, results have been released, and patient(s) received treatment or had treatment withheld based on the results reported.Diagnostica stago has received no details of treatment(s) changes.No serious injuries or deaths have been reported.
Additional Manufacturer Narrative
On 2023-01-29, the customer called the hotline to report and explain the event.On 2023-01-30, a service engineer (fse) was dispatched to the customer.No instrument problem was identified (the service engineer (fse) ran qc and precision for pt, ptt, fib, ddi, and hep assays.All results were in range).On (b)(6) 2023, the customer called the hotline to report that the instrument produced 3 other critical heparin (ufh) results ufh = 0.00 ui/ml.When samples were reran, the results were as follow: pid (b)(6) => initial result was 0.0 ((b)(6) 2023 7:09) ran on another unit ((b)(4)) and resulted 0.31 ((b)(6) 2023 7:25); pid (b)(6) => initial result was 0.00 ((b)(6) 2023 7:11) ran on other unit ((b)(4)) and resulted 0.30 ((b)(6) 2023 07:38); pid (b)(6) => initial result was 0.0 ((b)(6) 2023 7:09) reran on other unit ((b)(4)) and resulted 0.45 ((b)(6) 2023 7:24).Samples were capped.According to the customer, results haven't been released.On 2023-02-10, an fse was dispatched to the customer.No instrument problems were identified (verification of needle volumes, washing wells vacuum, and temperatures.All were in range.Fse ran qc and precision for pt, ptt, ddi, fib, and hep & patient samples.All were in range).The instrument data files were collected.Investigation is on-going.Diagnostica stago will provide a follow-up report once more relevant information is available.
Additional Manufacturer Narrative
On (b)(6) 2023, the customer called the hotline to report and explain the event.On 2023-01-30, a service engineer (fse) was dispatched to the customer.No instrument problem was identified (the service engineer (fse) ran qc and precision for pt, ptt, fib, ddi, and hep assays.All results were in range).On (b)(6) 2023, the customer called the hotline to report that the instrument produced 3 other critical heparin (ufh) results ufh = 0.00 ui/ml.When samples were reran, the results were as follow: pid (b)(6); initial result was 0.0 ((b)(6) 2023 7:09) ran on another unit ((b)(6)) and resulted 0.31 ((b)(6) 2023 7:25) pid (b)(6); initial result was 0.00 ((b)(6) 2023 7:11) ran on other unit ((b)(6)) and resulted 0.30 ((b)(6) 2023 07:38) pid (b)(6); initial result was 0.0 ((b)(6) 2023 7:09) reran on other unit ((b)(6)) and resulted 0.45 ((b)(6) 2023 7:24) samples were capped.According to the customer, results haven't been released.On 2023-02-10, an fse was dispatched to the customer.No instrument problems were identified (verification of needle volumes, washing wells vacuum, and temperatures.All were in range.Fse ran qc and precision for pt, ptt, ddi, fib, and hep & patient samples.All were in range.) the instrument data files were collected.Investigation is on-going.Diagnostica stago will provide a follow-up report once more relevant information is available.No files attached.Supplemental requested by fda _gen2500148.
Event or Problem Description
On 01/29/2023, the instrument produced critical heparin (ufh) results for 4 patients :ufh = 0.00 ui/ml.When samples were reran, the results were as follow: a.Initial result: <0.10, corrected: 0.49 drawn date/time: original: (b)(6) 2023 @ 06:31 corrected: 10:00.B.Initial result: <0.10, corrected: 0.82 drawn date/time: original: (b)(6) 2023 @ 06:05 corrected: 09:29.C.Initial result: <0.10, corrected: 0.17 drawn date/time: original: (b)(6) 2023 @ 07:22 corrected: 09:36.D.Initial result: <0.10, corrected: 0.68 drawn date/time: original: (b)(6) 2023 @ 07:22 corrected: 09:39.Samples were uncapped.According to the customer, results have been released, and patient(s) received treatment or had treatment withheld based on the results reported.Diagnostica stago has received no details of treatment(s) changes.No serious injuries or deaths have been reported.
Additional Manufacturer Narrative
Stago received additional information about the treatment change(s).According to the customer, following the release of erroneous results, there was an adjustment of the heparin ufh treatment for one patient but no serious injury associated.Investigations: the instrument data files have been analyzed by the stago support team in france and show that: -on the concerned patients' sample tubes (with erroneous results released), the plasma level detection occurred too high.These erroneous level detections may have resulted in air pipetting or partial sample pipetting which is consistent with wrong ufh <0.1 ui/ml results.The erroneous level detections can be explained by a problem on needle 1.-the issue appeared on (b)(6) 2023.-other samples and tests (as ddi/ aptt and pt) were affected by this issue.-there were numerous m>mmax alarms on aptt and pt tests (between (b)(6) and (b)(6) 2023).Following this analysis, a service engineer (fse) was dispatched to the customer on (b)(6) 2023 and lld (liquid level detection) cable of needle 1 has been replaced due to slightly loose.The fse performed additional maintenance actions and changed the needle.1, the needle 2 and the cap piercing tubing as a precaution.As all spare parts have been discarded, we were unable to analyze them.In order to check if the issue has been solved by this technical intervention, instrument data files has been collected again on march 21, 2023 and analyzed by the stago support team in france.The last data analysis shows that there were no further pipetting issue since (b)(6) 2023.Conclusion: the most likely root cause of these erroneous results was an issue on lld (liquid level detection) cable of needle 1 which has been replaced.We could not explain the fact that this cable was found loose on this analyzer.Stago has concluded its investigation in this matter and considers it is a confirmed and isolated event.We provided to our customer the list of all patients potentially affected by the issue and asked him to assess the impact on the concerned patients.To date and to our knowledge, there was no serious injury identified.Stago plans no further action.No files attached.Stago reference: (b)(4).Mdr submitted by the manufacturer.Supplemental requested by fda _(b)(4).

• Brand Name: STA COMPACT MAX
• Common Device Name: IVD COAGULATION DEVICE/INSTRUMENT
• Manufacturer (Section D): DIAGNOSTICA STAGO; 3 allée thérésa; asnieres sur seine, 92655 ; FR 92655
• Manufacturer Contact: walid ben ammar ; 3 allée thérésa; asnieres sur seine, 92 92655 ; FR 92655
• MDR Report Key: 16443703
• Report Number: 8043723-2023-00001
• Device Sequence Number: 20298514
• Product Code: JPA
• UDI-Device Identifier: 03607450589894
• UDI-Public: (01)03607450589894(11)170519(241)58989
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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
• 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: 01/29/2023
• Supplement Date Received by Manufacturer: 01/29/2023; Not provided
• Initial Report FDA Received Date: 02/27/2023
• Supplement Report FDA Received Date: 06/13/2025; 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/19/2017
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown