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

Model Number	IS (01)03607450589788(11)140312(21)4025362(241)5897858978
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There was poor vacuum at wash wells.The vacuum diaphragm was repaired.Investigations are still on going.
Event or Problem Description
On (b)(6) 2019, the customer reported six erroneous ptt results had been produced and released.Qc results were within range before and after the erroneous results were produced.The customer later indicated (questionnaire dated (b)(6) 2019) that there were five patients involved, and stated that there were no life-threatening or permanent effects on the patients.At least one of the patients did receive heparin therapy based on the erroneous results.
Additional Manufacturer Narrative
The field support engineer reseated the vacuum diaphragm due to a reduced vacuum measured at wash wells; it was not replaced.The fse then verified the valcor pump volume and remapped the needles to the wash wells, shuttle, and measurement plate.The dump files were analyzed and the following were determined: - qc was in range before and after the sample, therefore the reduced vacuum was not detected.- no alarm or alarm codes were produced.- no issue with sample detection or reagent detection was discovered.- it is not possible to detect the reduced vacuum in the dump files.The preliminary root cause has since been ruled out.If the root cause had been a failed diaphragm, it is very likely that the qc would have been affected and the erroneous results would have been more widespread.The engineer did inspect the pump diaphragm which was partially unseated but not damaged.The intermittent issue, where 5 patients experienced erroneous ptt results at different times in the same day, and not within the same run, is more consistent with a partially unseated diaphragm.Based upon the investigation, a 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.

• Brand Name: STA-R EVOLUTION
• Common Device Name: IVD COAGULATION DEVICE / INSTRUMENT
• Manufacturer (Section D): DIAGNOSTICA STAGO; 3 allée thérésa; asnières sur seine, 92600 ; FR 92600
• MDR Report Key: 9595574
• Report Number: 8043723-2020-00001
• Device Sequence Number: 2335360
• Product Code: JPA
• UDI-Device Identifier: 03607450589788
• UDI-Public: (01)03607450589788(11)140312(241)58978
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K082675
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2019

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: IS (01)03607450589788(11)140312(21)4025362(241)5897858978
• Initial Date Received by Manufacturer: 12/17/2019
• Supplement Date Received by Manufacturer: 12/17/2019
• Initial Report FDA Received Date: 01/16/2020
• Supplement Report FDA Received Date: 03/02/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other