MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XPT TOTAL HCG; TOTAL HCG IMMUNOASSAY

Model Number	N/A
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer has observed a discordant, elevated advia centaur xpt total (b)(6) result for one patient.An elevated result was obtained and questioned by the physician.Testing was repeated on the same sample, producing a lower result which was accepted as correct.There are no reports of patient harm, changes in treatment, or delays in diagnosis in association with the observed discordance.
Additional Manufacturer Narrative
A u.S.Customer reported a discordant, falsely elevated advia centaur xpt total (b)(6) result for one patient.Repeat testing produced a lower result, which was accepted as correct.The instructions for use (ifu) under the interpretation of results section states the following: "results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings." siemens is investigating.
Additional Manufacturer Narrative
Siemens healthcare diagnostics filed mdr 1219913-2022-00070 on 2022-02-23.Additional information, 2022-03-04: siemens has concluded the investigation.A united states customer reported observation of a discordant, elevated advia centaur xpt total hcg (thcg) result for one patient.An initial result >1000 miu/ml triggered re-testing following 5-fold dilution.The diluted sample produced a (dilution-corrected) result of 1650 miu/ml.This elevated result was questioned by the physician.Testing was repeated on the same sample, producing a lower result (150 miu/ml) which was accepted as correct.Siemens dispatched on-site service for this issue, and it was found that an aspiration probe on the advia centaur xpt instrument was leaking, and required replacement.Following probe replacement, thcg assay precision was verified, and the customer is now satisfied with the performance of the assay.This service intervention is considered normal troubleshooting or maintenance for issues of this nature, therefore return or investigation of the affected part is not warranted.A potential product issue has not been identified.The customer is operational, and no further investigation is required.

• Brand Name: ADVIA CENTAUR XPT TOTAL HCG
• Common Device Name: TOTAL HCG IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 333 coney street; east walpole MA 02032
• Manufacturer Contact: barry ; 333 coney street; east walpole, MA 02032 ; 5082985306
• MDR Report Key: 13588059
• Report Number: 1219913-2022-00070
• Device Sequence Number: 14968039
• Product Code: JHI
• UDI-Device Identifier: 00630414505176
• UDI-Public: 00630414505176
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K925279
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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): 03/23/2022

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 Expiration Date: 06/02/2022
• Device Model Number: N/A
• Device Catalogue Number: 10308985
• Device Lot Number: 335
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/21/2022
• Supplement Date Received by Manufacturer: 03/04/2022
• Initial Report FDA Received Date: 02/23/2022
• Supplement Report FDA Received Date: 03/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2021
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Male