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	06/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Falsely elevated total human chorionic gonadotropin (thcg) results were obtained on five 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 initial advia centaur cp instrument.The repeat results were lower than the erroneous results.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 falsely elevated thcg results.
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center to report that falsely elevated total human chorionic gonadotropin (thcg) results were obtained on five patient samples for total human chorionic gonadotropin (thcg) on an advia centaur cp instrument.Quality controls (qcs) recovered within ranges on the day of the event.A siemens customer service engineer was dispatched to the customer¿s site.During this visit, the cse inspected the instrument, found noise flags, and observed that the reagent probe was dripping when picking up reagent.The cse performed preventive maintenance (pm), cleared the noise flags, and resolved the reagent probe drip.Lastly, the cse ran qc in replicates of 5 and results recovered acceptably.The instrument is performing according to specifications.No further evaluation of this device is required.
Additional Manufacturer Narrative
Siemens filed initial mdr 2432235-2023-00194 on 28-jun-2023.Additional information (12-jul-2023): siemens further reviewed the incident.In addition to the noise flags, siemens determined that the base reagent was being consumed faster than the acid reagent.In addition to the service actions performed in the initial report, the siemens customer service engineer (cse) replaced the ionizer.Total human chorionic gonadotropin (thcg) precision and recoveries was acceptable post-service.The cause of the falsely elevated thcg results 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: christina lam ; 511 benedict ave.; tarrytown, NY 10591 ; 9142550090
• MDR Report Key: 17215757
• Report Number: 2432235-2023-00194
• Device Sequence Number: 6214352
• Product Code: JJE
• UDI-Device Identifier: 00630414523286
• UDI-Public: 00630414523286
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Followup
• Report Date (Section B): 07/24/2023

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
• 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: 06/02/2023
• Supplement Date Received by Manufacturer: 07/12/2023
• Initial Report FDA Received Date: 06/28/2023
• Supplement Report FDA Received Date: 07/24/2023
• 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 Sex: Unknown