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

Model Number	59027
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023, the instrument produced a heparin (ufh) result for 1 patient (id: (b)(6)) :ufh = 0.00 ui/ml (<0.1 ui/ml).Pharmacy questioned the result which caused the laboratory to rerun the sample.Sample was reran on the same instrument, the result was 0.76 ui/ml.Sample was capped.According to the customer, the erroneous result has been released but treatment was not changed.No serious injury or death have been reported.
Additional Manufacturer Narrative
On (b)(6) 2023, the customer called the hotline to report and explain the event.On (b)(6) 2023, a service engineer (fse) was dispatched to the customer and carried out several actions to solve the issue.On (b)(6) 2023, the customer called the hotline to report that the instrument produced another heparin (ufh) result ufh = 0.00 ui/ml (on id: (b)(6)) when samples were reran, the result was 1,04 ui/ml.According to the customer, this result hasn't been released.On (b)(6) 2023, the service engineer (fse) was dispatched again to the customer and carried out additional actions including the replacement of z1 cap piercing motor and the mapping of needle 1.No other similar call has been reported since this fse intervention.The instrument data files were collected and then analyzed by the stago support team in france.The analysis of the pipetting heights on the concerned patients' sample tubes (with erroneous results) 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 wrong ufh <0.1 ui/ml results.The most likely root cause of these erroneous results was an issue on z1 cap piercing motor which has been replaced.As z1 cap piercing motor was discarded, we were unable to analyze it.As other sample pipetting in the air were identified during the data files analysis, a list of all patients potentially affected by the issue will be provided to the customer in order to assess the impact on these patients.To date and to our knowledge, there was no serious injury identified.Stago has concluded its investigation in this matter and considers it is a confirmed and isolated event.Stago plans no further action.

• Brand Name: STA R MAX
• Common Device Name: IVD COAGULATION DEVICE/INSTRUMENT
• Manufacturer (Section D): DIAGNOSTICA STAGO; 2 rue pierre fossati; franconville, 95 95130 ; FR 95130
• Manufacturer Contact: walid ben ammar ; 2 rue pierre fossati; franconville, 95 95130 ; FR 95130
• MDR Report Key: 17497291
• Report Number: 8043723-2023-00005
• Device Sequence Number: 12461482
• Product Code: JPA
• UDI-Device Identifier: 03607450590272
• UDI-Public: (01)03607450590272(11)220406(241)59027
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 08/09/2023

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: 05/14/2023
• Initial Report FDA Received Date: 08/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2022
• 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