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

Model Number	59027
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During the night of (b)(6) 2021, the customer experienced an event whereby the sample needle (needle #1) hit a reagent vial and then the system crashed.The customer rebooted the system and continued to use it as it is.On (b)(6) 2021, the analyzer produced several discrepant results : 1 prolonged pt (not critical) 1 prolonged aptt (not critical) 1 critical heparin test result on (b)(6) 2021, the customer called the hotline to report and explain the event.On (b)(6) 2021, a service engineer (fse) was dispatched to the customer and found a bent needle #1.The fse straightened the needle #1 and remapped the arm.The instrument data files were collected and then later analyzed by the stago support team in france.An analysis of the pipetting heights on the concerned patients' sample tubes (with erroneous results released) showed that the plasma level detections occurred too high.These erroneous level detections may have resulted in pipetting in the air or partial sample pipetting which is consistent with prolonged pt and ptt or wrong ufh <0.1 ui/ml results.The erroneous level detections can be explained by a bent needle #1.No other similar call have been reported since the fse intervention.Conclusion: the most likely root cause of these erroneous results was a bent needle#1 caused by an impact/crash between the needle and a vial.The customer did not take the instrument out of use and request service after the crash.Stago has concluded its investigation in this matter and considers it is a confirmed and isolated event., stago plans no further action.
Event or Problem Description
On (b)(6) 2021, the instrument produced a critical heparin (ufh) result for 1 patient :ufh = 0 ui/ml.The sample was removed from the unit and was checked for clots, re-spun, and rerun without the cap and found at 0.78 ui/ml.According to the customer, the erroneous result was not released and no serious injury resulted.

• Brand Name: STA R MAX
• 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: 15691065
• Report Number: 8043723-2022-00001
• Device Sequence Number: 12439228
• Product Code: JPA
• UDI-Device Identifier: 03607450590272
• UDI-Public: (01)03607450590272(11)210504(241)59027
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 10/28/2022

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: 59027
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/02/2021
• Initial Report FDA Received Date: 10/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2021
• 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