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

Model Number	59010
Medical Device Problem Code	Use of Incorrect Control/Treatment Settings (1126)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cause of the incorrect setting is still under investigation.
Event or Problem Description
A customer (b)(6)) called the (b)(6) on (b)(6) 2019 to report a bias of -100% on stago 1 (s/n (b)(4)) vs.Stago 2 (s/n (b)(4)) for protein c testing.The pc results from (b)(6) 2018 until (b)(6) 2019 on stago 1 (s/n (b)(4)) were recovering approximately half of expected levels due to an incorrect dilution factor setting.
Additional Manufacturer Narrative
Investigation summary : the instrument (stago 1) was evaluated by both a field support engineer (fse) and a technical support specialist (tss).The sta-r max instrument was found to be within stago specifications and in good working order.However, an incorrect dilution "correction" factor was discovered for the pc-20 test.This corrector was set to 1 on stago 1 when it should have been 2.This was corrected immediately by the tss.Additionally, middleware data was reviewed by technical experts in the us and the advanced support team at the french manufacturing site reviewed system tracking files, and laboratory information system data provided by the customer.Findings : diagnostics stago has concluded that pc-20 results from (b)(6) 2019 were recovering approximately half of expected levels due the incorrect dilution factor.Root cause: the cause of the pc-20 result issue was an incorrect dilution "correction" factor setting on stago 1.Sna suspects that there was a setting error that originated by human error when stago and customer representatives met in person on (b)(6) 2018.Stago could not definitively confirm this suspected root cause, in part due to the fact that one of the persons directly involved in the meetings is no longer a stago employee and therefore could not be interviewed.Patient impact : we have no information about patients impact but we have to precise that these erroneous results could lead to a wrong treatment.Conclusion : we have concluded our investigations into this event.Please note that a vigilance will be added in the user manuals (sta-r max, sta compact max, sta satellite max) to avoid the problem : user methodology must be validated before releasing results.

• Brand Name: STA-R MAX
• Common Device Name: IVD COAGULATION DEVICE/INSTRUMENT
• Manufacturer (Section D): DIAGNOSTICA STAGO; 3 allée thérésa; asnières-sur-seine, 92600 ; FR 92600
• MDR Report Key: 9195643
• Report Number: 8043723-2019-00010
• Device Sequence Number: 3146799
• Product Code: JPA
• UDI-Device Identifier: 03607450590104
• UDI-Public: (01)03607450590104(11)18092015(241)59010
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K151867
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2019

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: 59010
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/04/2019
• Supplement Date Received by Manufacturer: 09/04/2019
• Initial Report FDA Received Date: 10/16/2019
• Supplement Report FDA Received Date: 11/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other