MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR CP TOTAL HCG (THCG); 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	09/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported observation of advia centaur cp total hcg (thcg) discordant (elevated) patient results with reagent lot 357.Initial results were reported, and a physician questioned a result.The patient samples were retested on a different advia centaur cp instrument and all results were lower and corrected reports were issued for (b)(4) samples.The customer found that quality control was in range before initially testing the patient samples, but as per their lab protocol, one qc level (l3) was run after patients, and it was just outside of range.The patient results had been released because it was considered acceptable.The initial instrument was re-calibrated, and samples were retested and were lower than the initial results.There are no allegations of patient harm, changes in treatment, or delays of diagnosis in association with this event.
Additional Manufacturer Narrative
Siemens concluded investigation for a customer report of discordant (elevated) patient results on the advia centaur cp total hcg (thcg) assay with reagent lot 357.On (b)(6) 2024, the customer states that all three levels of quality control (qc) were within range prior to running patient samples.Samples were tested, and following, they ran one level of qc that was just outside of their laboratory range.A physician also called and questioned a thcg value that resulted during this time.The customer retested the patient samples on a different advia centaur cp instrument and lower results were obtained and were reported as correct.Siemens customer service was dispatched to the customer site and performed a total service call to evaluate the system.The sample and reagent probe alignments were optimized, and the ionizer was replaced to address signal errors.Following service, thcg was recalibrated, and qc and master curve material was tested and recovered within acceptable limits.The system was left operational and the thcg assay is running within specification.The reported issue was resolved by routine service actions and recalibration.

• Brand Name: ADVIA CENTAUR CP TOTAL HCG (THCG)
• 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 # 1219913; east walpole MA 02032
• Manufacturer Contact: stacy loukos ; 333 coney st.; east walpole, MA 02032
• MDR Report Key: 20446709
• Report Number: 1219913-2024-00435
• Device Sequence Number: 8163980
• Product Code: DHA
• UDI-Device Identifier: 00630414505183
• UDI-Public: (01)00630414505183(10)47862357(17)241209
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/14/2024

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: 10331723
• Device Lot Number: 47862357
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/18/2024
• Initial Report FDA Received Date: 10/14/2024
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown