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

Model Number	10444834
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/10/2021
Type of Reportable Event	Malfunction
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 they are operational.The cause of this event is unknown.
Event or Problem Description
The customer reported a false positive troponin result for one patient on their cardiac scs instrument compared to repeated negative results on the same instrument.There was no report of injury due to this event.
Additional Manufacturer Narrative
The requested instrument log files were not provided.The customer stated they are operational.Review of the bimonthly testing being performed by the tech ops group showed no signs of unexpected upward drift for ctni lot 231214002.The root cause was unable to be determined.

• Brand Name: CARDIAC SCS
• Common Device Name: CARDIAC SCS
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC. - GLASGOW; 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: 12724027
• Report Number: 3002637618-2021-00065
• Device Sequence Number: 4103334
• Product Code: MMI
• UDI-Device Identifier: 00842768024863
• UDI-Public: 00842768024863
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• 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): 12/10/2021

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/10/2021
• Supplement Date Received by Manufacturer: 12/08/2021
• Initial Report FDA Received Date: 10/29/2021
• Supplement Report FDA Received Date: 12/10/2021
• 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