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

Model Number	ADVIA CENTAUR XP
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	02/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc) and reported that a non-reactive immunoglobulin g (igg) antibodies to hepatitis c virus (ahcv) result was obtained on a patient sample on an advia centaur xp instrument.Calibration was valid and quality control (qc) recovered within acceptable ranges on the day of the event.A siemens customer service engineer (cse) was dispatched to the customer's site.During the visit, the cse tested all dispense valves, replaced and primed acid pump, and determined there were no leaks at the fluid manifold.The cse determined the reagent 3 (r3) probe was bottoming out to cuvette and adjusted the height.The sample probe was also out of alignment and near the cuvette wall and the cse adjusted the alignment.Then, the cse emptied all acid, base, and wash 1 reservoirs and checked connections, bottles, and tubing, and did not observe any leaks; installed and primed new bottles; replaced aspirate probes pinch valve tubing; cleaned luminometer lens, performed an empty and fill cuvette procedure, ran dark counts, and primed water from reservoir to manifolds.As per the customer, the instrument has been operational.Although mechanical malfunctions were identified and addressed, since no other samples were impacted and qc recovered within ranges, preanalytical variables and sample integrity issues potentially contributed to the event.The instrument is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
The customer reported that a non-reactive immunoglobulin g (igg) antibodies to hepatitis c virus (ahcv) result was obtained on a patient sample on an advia centaur xp instrument.The non-reactive result was reported to the physician(s), who questioned the result based on the patient¿s historical result.The sample was repeated thrice on an alternate advia centaur xp instrument and since two of the three results were greater than or equal to 1.00 index value, the sample was considered reactive.The result of 1.03 index was reported as the correct result to the physician(s).The sample was also sent to an alternate laboratory for testing on an alternate methodology and the sample recovered non-reactive for ahcv.The same sample was subsequently repeated on original and alternate instruments for troubleshooting purposes.There are no known reports of patient intervention or adverse health consequences due to the non-reactive ahcv result.

• Brand Name: ADVIA CENTAUR XP
• Common Device Name: ADVIA CENTAUR XP
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LIMITED; chapel lane, swords, co.; registration number: 8020888; dublin ; EI
• Manufacturer Contact: christina lam ; 511 benedict ave.; tarrytown, NY 10591 ; 9142550090
• MDR Report Key: 18852369
• Report Number: 2432235-2024-00044
• Device Sequence Number: 20686682
• Product Code: JJE
• UDI-Device Identifier: 00630414573564
• UDI-Public: 00630414573564
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K141999
• 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): 03/06/2024

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 XP
• Device Catalogue Number: 10364455
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/09/2024
• Initial Report FDA Received Date: 03/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/29/2014
• 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