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

Model Number	ADVIA CENTAUR CP IMMUNOASSAY SYSTEM
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that a falsely elevated high-sensitivity troponin i (tnih) result was obtained on a patient sample on an advia centaur cp immunoassay system.The erroneous result was reported to the physician(s).Two hours later, the patient¿s blood was redrawn, and the new sample was processed on the same instrument.The result was inconsistent with the prior sample result.Then, the latter sample was repeated in duplicate on the original instrument and the repeat results recovered higher.Next, the first sample was repeated on the original instrument and the sample recovered lower.Then, both samples were repeated on the non-siemens instrument and recovered lower than the erroneous results.The repeat results from the non-siemens instrument were considered correct and reported to the physician(s).The customer mentioned that inconsistent tnih results were obtained on samples from other patients but did not provide the associated patient data.There are no known reports of patient intervention or adverse health consequences due to the falsely elevated tnih results.
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc) and reported that falsely elevated high-sensitivity troponin i (tnih) results were obtained on a patient sample on an advia centaur cp immunoassay system.Quality control (qc) was valid prior to sample processing.The customer performed a precision check using qc, which recovered acceptably.It was determined that the reagent probe (rp) was bent.A siemens customer service engineer (cse) was dispatched to the customer's site.During the visit, the cse inspected the instrument, performed total service and preventative maintenance, replaced the rp, rp tubing, and the bubble detector sensor assembly, and ran qc, which recovered acceptably.Siemens further evaluated the event and concluded that the system malfunction, addressed with the service actions above, potentially contributed to the falsely elevated tnih results.The instrument is performing according to specifications.No further evaluation of this device is required.

• Brand Name: ADVIA CENTAUR CP IMMUNOASSAY SYSTEM
• Common Device Name: ADVIA CENTAUR CP IMMUNOASSAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): STRATEC BIOMEDICAL SWITZERLAND AG; neuwiesenstrasse 4; registration #: 3008494306; beringen 8222 ; SZ 8222
• Manufacturer Contact: emmanuella makridakis ; 511 benedict ave.; tarrytown, NY 10591 ; 9086354191
• MDR Report Key: 20042737
• Report Number: 2432235-2024-00194
• Device Sequence Number: 20825972
• Product Code: JJE
• UDI-Device Identifier: 00630414523286
• UDI-Public: (01)00630414523286
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 08/22/2024

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 IMMUNOASSAY SYSTEM
• 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: 07/30/2024
• Initial Report FDA Received Date: 08/22/2024
• 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 Age: 59 YR
• Patient Sex: Female