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

Model Number	10444834
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer stated that repeat testing was performed to confirm correct results, and a corrected report was issued.Also stated was that qc was performed, and are within the expected ranges.Siemens service was dispatched: preventive maintenance was conducted in accordance with the checklist, including visual inspection, cleaning, greasing and alignment checks.100 ul syringe, fluorometer lamp and pressure disk were exchanged as part of pm.Y alignment conducted and auto alignment were carried out.After over one hour of the analyzer being switched on, the fluorometer lamp was calibrated.Carousel temperature checked - 37.0 degrees.Analyzer was calibrated for d-dimer method, the system check was conducted, and two levels of qc ran successfully.The customer stated they are operational.Siemens has asked several times for the message logs to be sent for further investigation but none have been received.The cause of this event is unknown.
Event or Problem Description
The customer reported a discrepant low d-dimer result on the stratus cs analyzer when compared to a non-siemens lab analyzer.The customer stated an ultrasound scan was delayed by one day.There is no report of injury due to this event.

• Brand Name: STRATUS CS
• Common Device Name: STRATUS CS
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC. - GLASGOW; glasgow business community; newark DE 19702
• MDR Report Key: 10642352
• Report Number: 3002637618-2020-00054
• Device Sequence Number: 16795468
• Product Code: MMI
• UDI-Device Identifier: 00842768024863
• UDI-Public: 00842768024863
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K051650
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 10/07/2020

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 Model Number: 10444834
• Device Catalogue Number: 10444834
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/17/2020
• Initial Report FDA Received Date: 10/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1