MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR TOTAL HCG; 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	09/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A customer from outside the united states reported observation of a depressed atellica im thcg result which was discordant relative to alternate-method testing.A siemens engineer checked the system following this observation, and identified some crystallization at the sample dispense port, which was cleaned.The interpretation of results section of the advia centaur thcg instructions for use states: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings." siemens is investigating.
Event or Problem Description
The customer reports observation of an advia centaur advia centaur total hcg (thcg) result which was discordant relative to repeat testing when using thcg lot 357.An initial elevated thcg result was obtained for a female patient with abnormal uterine bleeding.Testing following 100- and 200-fold dilution produced ¿error¿ results.When the patient¿s sample was tested using an hcg test strip, a negative result was obtained, and considered consistent with the patient¿s clinical condition.There are no allegations of any adverse patient effects in association with the observed discordance.
Additional Manufacturer Narrative
A customer from outside the united states reported observation of a depressed atellica im thcg result which was discordant relative to alternate-method testing.An initial elevated thcg result was obtained for a female patient with abnormal uterine bleeding.Testing following 100- and 200-fold dilution produced ¿error¿ results.When the patient¿s sample was tested using an hcg test strip, a negative result was obtained, and considered consistent with the patient¿s clinical condition.Review of customer data showed that quality control (qc) results were within expected ranges, and no issues were identified with any other samples, indicating that the assay reagent is not the likely cause.A siemens engineer checked the system following this observation, and identified some crystallization at the sample dispense port, which was cleaned.Following this routine service intervention, the system was fully operational and the customer had no further concerns.No product problem was identified, and the issue was resolved through routine troubleshooting.Note: in section h6, codes for investigation findings and investigation conclusions have been updated.

• Brand Name: ADVIA CENTAUR TOTAL HCG
• Common Device Name: SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 333 coney st.; registration no. 1219913; east walpole MA 02032
• Manufacturer Contact: barry memishian ; 333 coney st.; east walpole, MA 02032 ; 5082985306
• MDR Report Key: 20522888
• Report Number: 1219913-2024-00451
• Device Sequence Number: 7969359
• Product Code: DHA
• UDI-Device Identifier: 00630414505176
• UDI-Public: (01)00630414505176(10)44481357(17)20241209
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K200210
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2024

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: 12/09/2024
• Device Model Number: N/A
• Device Catalogue Number: 10308985
• Device Lot Number: 44481357
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/23/2024
• Supplement Date Received by Manufacturer: 11/07/2024
• Initial Report FDA Received Date: 10/24/2024
• Supplement Report FDA Received Date: 11/07/2024
• Date Device Manufactured: 02/09/2024
• 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 Sex: Unknown