MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. - GLASGOW STRATUS CS

Catalog Number	10444834
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer was unable to provide instrument log files for the date of the event.Investigation is underway into the performance of the reagent lot in question.The cause of this event is unknown.
Event or Problem Description
Customer reported that their stratus cs instrument gave a false positive ctni result compared to retesting of the same sample on the same instrument several hours apart.There is no report of injury due to this event.
Additional Manufacturer Narrative
Siemens has completed the investigation.The customer sent instrument log files for investigation.Root cause was unable to be determined for the discrepant ctni on the customer's stratus instrument.A review of the calibration and quality control data for the reagent lot in use that the time of the discrepancy demonstrated the reagent and instrument were working as intended.A review of the manufacturing release data for the lot demonstrated acceptable performance, nothing atypical was observed, instrument is operating as intended.The cause of this event is unknown.

• Brand Name: STRATUS CS
• Common Device Name: STRATUS CS
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC. - GLASGOW; 500 gbc drive; po box 6101; newark DE 19714
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 62 flanders-bartley rd.; flanders NJ 07836
• Manufacturer Contact: felix akinrinola ; 2 edgewater drive; norwood, MA 02062
• MDR Report Key: 17868084
• Report Number: 3002637618-2023-00079
• Device Sequence Number: 14826100
• Product Code: MMI
• UDI-Device Identifier: 00842768024863
• UDI-Public: 00842768024863
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K051650
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 10444834
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2023
• Supplement Date Received by Manufacturer: 10/24/2023
• Initial Report FDA Received Date: 10/04/2023
• Supplement Report FDA Received Date: 10/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Sex: Male