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	07/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A falsely elevated high sensitivity troponin i (tnih) result was obtained on a patient sample on an advia centaur cp analyzer.The erroneous result was reported to the physician(s).A second sample from the patient was drawn and run one hour later for tnih on the advia centaur cp analyzer, recovering lower.After receiving the result from the second sample, the physician(s) questioned the erroneous result.The initial sample was then rerun for tnih on the advia centaur cp analyzer as well as on an advia centaur xp analyzer, both times recovering lower than the initial result.The lower result was reported, as the correct result, to the physician(s).A third sample from the patient was then run for tnih on the advia centaur cp analyzer, also recovering lower.There are no known reports of patient intervention or adverse health consequences due to the falsely elevated tnih result.
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc).Quality control was within range several hours prior to running the sample.A siemens customer service engineer (cse) was dispatched to the customer's site.The cse inspected the advia centaur cp analyzer and found a leaking tubing to the rinse block.The tube was repaired and tested by the cse.The analyzer was fully operational upon completion of the service visit.Inconsistent wash of the sample potentially contributed to the initial elevated result.The analyzer is performing according to specifications.No further evaluation of the analyzer is required.

• Brand Name: ADVIA CENTAUR CP ANALYZER
• 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; gewerbestrasse 6; neuhausen am rheinfall 8212 ; SZ 8212
• Manufacturer Contact: christopher aebig ; 511 benedict ave.; tarrytown, NY 10591 ; 9144153450
• MDR Report Key: 17618993
• Report Number: 2432235-2023-00240
• Device Sequence Number: 16796554
• Product Code: JJE
• UDI-Device Identifier: 00630414523286
• UDI-Public: 00630414523286
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/24/2023

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: 08/01/2023
• Initial Report FDA Received Date: 08/24/2023
• 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 Age: 40 YR
• Patient Sex: Unknown