MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADIVA CENTAUR; 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	03/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer reported observation of an elevated high sensitivity troponin i (tnih) result which was erroneous relative to repeat testing.Reagent issues were ruled out based on review of quality control (qc), which showed recovery within acceptable ranges and no issues were reported with other patient samples.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During the visit, the cse inspected the instrument and replaced blue peristaltic pump tubing, #2 rinse block, acid/base reagents and verified fluidics.Post-service qc, patient sample replicates and precision check produced expected results.Return of the patient sample for further investigation was not warranted because the erroneous result was not reproducible.The probable cause of the erroneously elevated tnih result could not be determined, as multiple parts were replaced and serviced as part of standard service actions.A product problem was not identified.The instrument is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
The customer reports observation of an elevated high sensitivity troponin i (tnih) result which was erroneous relative to repeat testing when using lot# 113 on an adiva centaur cp analyzer (s/n:(b)(6)).An initial elevated tnih result was observed for a patient sample in question.The elevated result was reported to the physician(s), who did not question the result.The same sample was then retested on the original analyzer and also using an alternate methodology which produced lower results.The lower results were considered correct, and a corrected report with a result of 4.80 pg/ml was issued to the physician(s).There are no known reports of patient intervention or adverse health consequences due to this event.

• Brand Name: ADIVA CENTAUR
• Common Device Name: ADVIA CENTAUR CP ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave.; tarrytown NY 10591
• Manufacturer (Section G): STRATEC BIOMEDICAL SWITZERLAND AG; registration #: 3008494306; neuwiesenstrasse 4; beringen 8222 ; SZ 8222
• Manufacturer Contact: varsha joshi ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 870577433
• MDR Report Key: 24737175
• Report Number: 2432235-2026-00084
• Device Sequence Number: 9214788
• Product Code: JJE
• UDI-Device Identifier: 00630414523286
• UDI-Public: (01)00630414523286
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K041133
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/30/2026

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): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 03/30/2026
• 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: Female