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

Model Number	10444834
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that their stratus cs instrument provided a false positive troponin result compared to retesting of the same sample on the same instrument.There is no report of injury due to this event.
Additional Manufacturer Narrative
Siemens has requested instrument log files for further investigation.Investigation is underway.The cause of this event is unknown.
Additional Manufacturer Narrative
The root cause was unable to be determined for the falsely elevated ctni results of 0.07.The log file for the day of the escalated event (b)(6) was not available for analysis.A review of internal performance data for test pak lot in question showed that the testpak lot is working as expected.The customer provided log file for the instrument containing four days ((b)(6) 2022) worth of data following the day of escalated event.No system performance related anomaly was detected in any sample signal during review of the log file.The stratus cs appears to be functioning as expected.

• Brand Name: STRATUS CS
• Common Device Name: STRATUS CS
• Manufacturer (Section D): MENS HEALTHCARE DIAGNOSTICS INC. - GLASGOW; 500 gbc drive; newark DE 19714
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 62 flanders-bartley rd.; flanders NJ 07836
• Manufacturer Contact: thomas myers ; 511 benedict avenue; tarrytown, NY 10591
• MDR Report Key: 16067244
• Report Number: 3002637618-2022-00081
• Device Sequence Number: 11267608
• Product Code: MMI
• UDI-Device Identifier: 00842768024863
• UDI-Public: 00842768024863
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2023

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 Model Number: 10444834
• Device Catalogue Number: 10444834
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/22/2022
• Supplement Date Received by Manufacturer: 01/27/2023
• Initial Report FDA Received Date: 12/29/2022
• Supplement Report FDA Received Date: 02/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown