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

Model Number	ADVIA CENTAUR CP
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center to report that erroneous total human chorionic gonadotropin (thcg) results were obtained on two patient samples on an advia centaur cp instrument.Quality controls (qcs) recovered within ranges on the day of the event.A siemens customer service engineer (cse) was dispatched to the customer's site.During this visit, the cse performed a full system check and observed corrosion on both rinse blocks.The cse replaced the rinse blocks, blue aspirate wash around pump, blue and grey peri pump tubing, and four aspirate probe clear tubing.Next, the cse checked probe calibrations and primed the wash station.Quality control and calibration were performed by the customer, which recovered within ranges.There were no issues reported with qc or patients results post service.The cause of erroneous thcg results is unknown.The system is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
Erroneous total human chorionic gonadotropin (thcg) results were obtained on two patient samples on an advia centaur cp instrument.The erroneous results were reported to the physician(s), who questioned the results.The samples were repeated on the same instrument.The repeat results were reported, as the correct results, to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the erroneous thcg patient results.

• 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: 16976480
• Report Number: 2432235-2023-00115
• Device Sequence Number: 11342299
• 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): 05/22/2023

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: 04/27/2023
• Initial Report FDA Received Date: 05/22/2023
• 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