MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. - GLASCOW CARDIAC SCS

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	12/12/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported a false positive cardiac troponin for one patient on the cardiac scs compared to two repeats which were negative.There was no report of injury due to this event.
Additional Manufacturer Narrative
The customer stated that repeat testing was performed to confirm correct results which met the clinical picture and a corrected report was issued.Siemens has requested the message logs for investigation.The customer stated that proper technique, sample handling and maintenance were reviewed with the operators and the issue was not related to the lack of required maintenance.The customer stated they are operational but are rerunning every positive sample.The cause of this event is unknown.
Event or Problem Description
The customer reported a false positive cardiac troponin for one patient on the cardiac scs compared to two repeats which were negative.There was no report of injury due to this event.
Additional Manufacturer Narrative
The customer stated that repeat testing was performed to confirm correct results which met the clinical picture and a corrected report was issued.Siemens has requested the message logs for investigation.The customer stated that proper technique, sample handling and maintenance were reviewed with the operators and the issue was not related to the lack of required maintenance.The customer stated they are operational but are rerunning every positive sample.The cause of this event is unknown.
Additional Manufacturer Narrative
Siemens has shown due diligence in requesting instrument log files from the customer however the customer was unable to provide the requested information.Siemens has reviewed the performance data for the lot in question and the lot is performing as expected.The cause of this event is unknown.

• Brand Name: CARDIAC SCS
• Common Device Name: CARDIAC SCS
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC. - GLASCOW; glasgow business community; newark DE 19702
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 62 flanders-bartly rd.; flanders NJ 07836
• Manufacturer Contact: felix akinrinola ; 511 benedict avenue; tarrytown, NY 10591
• MDR Report Key: 13063728
• Report Number: 3002637618-2021-00075
• Device Sequence Number: 6010199
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2022

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?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/16/2021
• Supplement Date Received by Manufacturer: 02/04/2022
• Initial Report FDA Received Date: 12/22/2021
• Supplement Report FDA Received Date: 02/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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