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

Model Number	ADVIA CENTAUR XP
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Falsely elevated high sensitivity troponin i (tnih) results were generated on two patient samples on an advia centaur xp analyzer.The initial results were reported to the physician(s).The customer reported that due to the erroneous results, the patients were given dual anti-platelet treatment and admitted to the accident and emergency department, where their urine and electrolytes routine tests, liver function, bone profile, c-reactive protein (crp) and amylase were evaluated.Additionally, these patients were potentially listed for an angiogram.The customer repeated the samples, and the results were lower than the erroneous results.The customer indicated that other samples were potentially impacted but did not provide the associated data.There were no reports of adverse health consequences due to the falsely elevated tnih results.
Additional Manufacturer Narrative
An outside the united states (ous) customer contacted a siemens customer care center (ccc) to report that falsely elevated high sensitivity troponin i (tnih) results were generated on two patient samples on an advia centaur xp analyzer.It was determined that the grounding cable for the aspirate probe was loose, and the grounding cable was replaced.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During this visit, the cse performed a total service call, adjusted reagent probe 1 (rp1) to reagent light bottom level, cleaned and lubricated the diluters, and carried out successful dark count tests with and without cuvettes.Next, the cse checked vacuum flow and vacuum regulator, which were acceptable.Then, the cse replaced and tested the manifold connectors rp1 and reagent probe 2 wash 1, remade tubing to cuvette waste, and performed successful acid and base dispense check.After that, the cse performed daily maintenance and cleaned the ionizer.Then, the cse requested for the customer to run qc and samples.The cause of the event is unknown.The instrument is performing according to specifications.No further evaluation of this device is required.
Additional Manufacturer Narrative
Siemens filed initial mdr 2432235-2024-00039 with the fda on 23-feb-2024.Additional information (01-mar-2024): in the initial report, section b5 indicated that ¿the customer indicated that other samples were potentially impacted but did not provide the associated data.¿ aside from the patients reported in the initial report and mdr 2432235-2024-00038, the customer clarified that when the other samples were repeated, the repeat results matched the initial results.The customer also reported that the patients were male.A3 was updated to reflect the additional information.Additionally, the customer indicated that the treatments for acute coronary syndrome was stopped, without any reported harm.Siemens assessed the quality control (qc) results and found that level 3 qc was elevated for one replicate following the erroneous results.Siemens concluded that the instrument malfunctions that were addressed with the service activities mentioned in the initial report potentially contributed to the high sensitivity troponin i (tnih) results.The investigation conclusion code was updated to reflect the evaluation conclusion.The instrument is performing according to specifications.No further evaluation of this device is required.Mdr 2432235-2024-00038 and the associated supplemental report were filed for the same event.

• Brand Name: ADVIA CENTAUR XP
• Common Device Name: ADVIA CENTAUR XP
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD; chapel lane, swords co.; registration number: 8020888; dublin ; EI
• Manufacturer Contact: douglas stanton ; 511 benedict avenue; tarrytown, NY 10591 ; 9142706592
• MDR Report Key: 18773179
• Report Number: 2432235-2024-00039
• Device Sequence Number: 7739040
• Product Code: JJE
• UDI-Device Identifier: 00630414573564
• UDI-Public: 00630414573564
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Followup
• Report Date (Section B): 03/19/2024

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 XP
• Device Catalogue Number: 10364455
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/15/2024
• Supplement Date Received by Manufacturer: 03/01/2024
• Initial Report FDA Received Date: 02/23/2024
• Supplement Report FDA Received Date: 03/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2014
• 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: Male