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

Model Number	ADVIA CENTAUR CP
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A negative total human chorionic gonadotropin (thcg) result was obtained on a patient sample on an advia centaur cp instrument.The sample was repeated on the same instrument, which recovered falsely elevated.The sample was sent to the main lab and repeated on an alternate atellica analyzer, which recovered lower than the erroneous result.On the subsequent day, the sample was repeated on the initial advia centaur cp instrument, and the result correlated with the result obtained on the atellica im analyzer.There are no known reports of patient intervention or adverse health consequences due to the erroneous thcg result.
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center to report an erroneous total human chorionic gonadotropin (thcg) result was obtained on a patient sample on an advia centaur cp instrument.Quality controls (qcs) recovered within ranges on the day of the event.The customer ran qc after the patient sample was run and the qc recovered within ranges.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During this visit, the cse verified the acid and base dispense was correct at 3 ml.The cse realigned reagent probe to all test points and made minor adjustments.Then, the customer ran a precision study and qc, which recovered acceptably.The cause of the falsely elevated thcg result is unknown.The instrument is performing according to specifications.No further evaluation of this device is required.

• Brand Name: ADVIA CENTAUR CP
• Common Device Name: ADVIA CENTAUR CP
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): STRATEC BIOMEDICAL SWITZERLAND AG; neuwiesenstrasse 4; registration #: 3008494306; beringen 8222 ; SZ 8222
• Manufacturer Contact: kristin kehyaian ; 511 benedict ave.; tarrytown, NY 10591 ; 9148267101
• MDR Report Key: 17970121
• Report Number: 2432235-2023-00278
• Device Sequence Number: 12462496
• Product Code: JJE
• UDI-Device Identifier: 00630414523286
• UDI-Public: 00630414523286
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 10/19/2023

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
• 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: 09/27/2023
• Initial Report FDA Received Date: 10/19/2023
• 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