MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR CP ANALYZER

Model Number	ADVIA CENTAUR CP ANALYZER
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A falsely elevated high-sensitivity troponin i (tnih) patient result was obtained on an advia centaur cp instrument.The result was reported to the physician(s).The customer used the same instrument and an alternate advia centaur cp to perform repeat.The customer obtained similar lower results on both instruments.The repeat results were considered correct, and a corrected report was issued.Siemens investigated the event log and noted no flag or error when the advia centaur cp ran the sample.Siemens inspected the sample and observed suspended particles in the serum sample.The customer stated that the patient tested tnih from (b)(6) 2024 to (b)(6) 2024, and suspended particles were in three samples.Siemens dispatched a customer service engineer (cse).The cse replaced the wash 1 pump, performed testing, noted that the tnih imprecision did not recur, and resolved the issue.Siemens reviewed the information provided, which included the tnih ifu, and confirmed the following: do not to use specimens with apparent contamination.Before placing samples in the system, ensure that samples are free of bubbles or foam, fibrin, or other particulate matter.If clotting time is increased due to thrombolytic or anticoagulant therapy, using serum samples may increase the risk of micro-clots, fibrin, or particulate matter.Siemens noted the cse performed the necessary hardware inspection and services as part of troubleshooting and noted no recurrence.The sample integrity cannot be ruled out as the potential cause for the falsely elevated result.The advia centaur cp analyzer is operating as specified.No further action was required.
Event or Problem Description
A falsely elevated high-sensitivity troponin i (tnih) patient result was obtained on an advia centaur cp instrument.The result was reported to the physician(s).The customer used the same instrument and an alternate advia centaur cp to perform repeat.The customer obtained similar lower results on both instruments.The repeat results were considered correct, and a corrected report was issued.There are no known reports of patient intervention or adverse health consequences due to the event.

• Brand Name: ADVIA CENTAUR CP ANALYZER
• Common Device Name: ADVIA CENTAUR CP ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): STRATEC BIOMEDICAL SWITZERLAND AG; neuwiesenstrasse 4; beringen 8222 ; SZ 8222
• Manufacturer Contact: rolando hualpa ; 511 benedict ave.; tarrytown, NY 10591 ; 9143485874
• MDR Report Key: 18670829
• Report Number: 2432235-2024-00033
• Device Sequence Number: 7128364
• Product Code: JJE
• UDI-Device Identifier: 00630414523286
• UDI-Public: 00630414523286
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K041133
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/08/2024

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: ADVIA CENTAUR CP ANALYZER
• Device Catalogue Number: 10309710
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/24/2024
• Initial Report FDA Received Date: 02/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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