MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR TOTAL HCG (THCG) ASSAY; SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN

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	08/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reports observation of an elevated result for a female patient with the advia centaur xpt thcg lot 359.The initial result was reported to the physician(s) who questioned the result.The interpretation of results section of the advia centaur total hcg (thcg) instructions for use (ifu) states: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings." siemens healthcare diagnostics is investigating.
Event or Problem Description
The customer reports observation of an elevated result for a female patient with the advia centaur xpt thcg lot 359.The initial result was reported to the physician(s) who questioned the result.The redrawn sample was repeated on the same analyzer; the sample recovered less than the analytical measurement range vs.The initial result.The repeat result was reported to the physician(s) as a correct result.A corrected report was issued based on the repeat testing.There are no known reports of patient intervention or adverse health consequences due to this event.
Additional Manufacturer Narrative
Mdr was initially filed on 07-sep-2024.Additional information (15-oct-2024): siemens healthcare diagnostics has concluded the investigation of the event.The customer obtained an elevated result for a female patient with the advia centaur xpt total hcg (thcg) assay with reagent lot 359.On (b)(6) 2024, the sample initially resulted 106 miu/ml which was questioned by the physician.The patient was redrawn on (b)(6) 2024, and the thcg result was <1.00 miu/ml.The lower value was accepted as being correct and the initial result was seen as being discordant.Bio-rad immunoassay plus qc lot 40440 recovered within acceptable ranges on both days of testing.No issues were reported with other patient samples tested on the day the discordant result was obtained.Siemens provided instrument service and there is no report of discordance post service.Based on the available information, the cause of the discordant result is inconclusive and considered an isolated patient specific event.The customer is operational, and the reported issue was resolved by routine troubleshooting.Note: in section h6, the codes for investigation findings and investigation conclusions have been updated.

• Brand Name: ADVIA CENTAUR TOTAL HCG (THCG) ASSAY
• Common Device Name: SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591 5097
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 333 coney street; east walpole MA 02032
• Manufacturer Contact: stacy loukos ; 333 coney st.; east walpole; east walpole, MA 02032
• MDR Report Key: 20164935
• Report Number: 1219913-2024-00402
• Device Sequence Number: 20655931
• Product Code: DHA
• UDI-Device Identifier: 00630414505176
• UDI-Public: (01)00630414505176(10)76509359(17)250222
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K200210
• 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): 10/29/2024

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 Expiration Date: 02/22/2025
• Device Model Number: N/A
• Device Catalogue Number: 10308985
• Device Lot Number: 76509359
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/16/2024
• Supplement Date Received by Manufacturer: 10/15/2024
• Initial Report FDA Received Date: 09/07/2024
• Supplement Report FDA Received Date: 10/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/22/2024
• 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 Age: 35 YR
• Patient Sex: Female