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	12/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer reported that a discordant human chorionic gonadotropin (thcg) patient result was obtained on an advia centaur cp instrument.The customer contacted the siemens customer care center (ccc) and a siemens customer service engineer (cse) was dispatched to the customer's site and inspected the instrument.The cse stated that the system reported several wash station aspiration errors at multiple positions.The grey peri tubing were replaced and the bubble detectors were recalibrated.The aspirate probe tubing still contained fluids/bubbles, so the waste pump was also replaced.System was fully operational upon departure.The instrument is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
A discordant human chorionic gonadotropin (thcg) patient result was obtained on an advia centaur cp instrument.The initial result was reported to the physician(s) and questioned.The same sample was repeated on the same instrument.It is unknown if the repeat result was considered the correct result and reported to the physician(s).There were no known reports of patient intervention or adverse health consequence due to this event.

• 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: eric so ; 511 benedict ave.; tarrytown, NY 10591 ; 2012144764
• MDR Report Key: 18408821
• Report Number: 2432235-2023-00341
• Device Sequence Number: 14185972
• 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): 12/28/2023

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): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2023
• Initial Report FDA Received Date: 12/28/2023
• 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 Sex: Female