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

Model Number	ADVIA CENTAUR XP ANALYZER
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center to report false reactive hepatitis b surface antigen hbsagii (hbsii) and hepatitis b surface antigen (hbsag) confirmatory (conf) results were obtained on a patient sample on the advia centaur xp analyzer.The instrument had errors related to the incubation ring movement.The customer performed troubleshooting by performing an empty and fill ring.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During this visit, the cse found the cuvette chute was not aligned and there was a breakage in tubing of the aspiration probe 2.The cuvette chute was aligned, and tubing was replaced.The vessels were loaded and unloaded 4 times and proper aspiration was verified.The customer ran quality controls (qcs), which recovered within ranges.The hbsagii assay may be used in conjunction with other serological and clinical information to diagnose individuals with acute or chronic hepatitis b infection and screen for hepatitis b infection in pregnant women to identify neonates who are at risk of acquiring hepatitis b during the perinatal period.The customer indicated as per the hospital¿s policy, the patient underwent a caesarean section based on the discordant hbsagii results.However, complete patient details such as weeks of gestation, obstetric history, and the clinical condition of the fetus at the time of labor were not provided.Caesarean section is recommended in situations where normal vaginal delivery can pose risks to either the mother, baby, or both; these situations include prolonged or obstructed labor, fetal distress, elevated blood pressure or glucose, multiple pregnancies, or abnormal presentation/position of the baby among others and even personal choice of the healthy mother.According to the society for maternal-fetal medicine (smfm), caesarean delivery is not recommended for the sole indication of reducing perinatal hepatitis b virus transmission.Siemens further evaluated the event and concluded that instrument related issues potentially contributed to the false reactive hbsii and hbsag conf patient results.The instrument is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
The customer reported that a false reactive hepatitis b surface antigen hbsagii (hbsii) result was obtained on a patient sample on an advia centaur xp analyzer.The erroneous result was reported to the physician(s).The customer repeated the sample in duplicate and obtained reactive results.The customer performed confirmatory testing using the hepatitis b surface antigen (hbsag) confirmatory (conf) assay and the sample was confirmed to be reactive.The customer indicated based on the hospital's policy, since the patient was confirmed for being hbsag reactive and was in labor, the patient underwent a caesarean section.Then, the customer recalibrated the assay and repeated the sample on the same instrument.The repeat results were non-reactive.The non-reactive repeat result for hbsii was reported, as the correct result, to the physician(s).

• Brand Name: ADVIA CENTAUR XP ANALYZER
• Common Device Name: ADVIA CENTAUR XP ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave.; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD.; chapel lane, swords, co.; registration number: 8020888; dublin ; EI
• Manufacturer Contact: kristin kehyaian ; 511 benedict ave.; tarrytown, NY 10591 ; 9148267101
• MDR Report Key: 20917084
• Report Number: 2432235-2024-00346
• Device Sequence Number: 8320630
• Product Code: JJE
• UDI-Device Identifier: 00630414573564
• UDI-Public: (01)00630414573564
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 12/12/2024

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 ANALYZER
• Device Catalogue Number: 10364455
• 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: 11/20/2024
• Initial Report FDA Received Date: 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/20/2017
• 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 Age: 26 YR
• Patient Sex: Female