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	Imprecise or Erratic Results (4059)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A customer from outside the united states reported observation of divergent advia centaur total hcg (thcg) results for one patient in repeat testing.There were no instrument errors observed, and quality control (qc) result have been within expected ranges.No issues were noted for any other patient samples.Siemens is investigating.
Event or Problem Description
The customer reports observation of divergent advia centaur total hcg (thcg) results for one patient when running thcg lot 355.An initial thcg result above reference range for non-pregnant females was obtained for a 31-year-old female patient (no details provided).The test was repeated using the same sample according to local protocol, and the second test produced a result below assay measuring interval (<4.0 miu/ml).Due to the observed difference between results, a third test was run, and another result below measuring interval was obtained.A ¿negative¿ result was reported for the patient.A week later, while validating a new thcg kit lot, the affected sample was re-tested following refrigerated storage as part of the evaluation.This sample, when tested with new thcg lot 357, produced a much higher result (above reference range for non-pregnant females).When the same sample was repeat-tested, the higher result was reproduced.The customer is uncertain which result to consider correct.There are no allegations of any adverse patient consequences in association with the observed result discordance.
Additional Manufacturer Narrative
Mdr 1219913-2024-00386 was initially submitted on 16-aug-2024.Update, august 2024: siemens has concluded the investigation.A customer from the united states reported observation of divergent advia centaur total hcg (thcg) results for one patient when running atellica im thcg.In repeated testing, this patient's sample produced variable results.No instrument errors occurred during this timeframe, and a siemens service engineer performed a full system check and verified normal instrument operation.Quality control (qc) results have been within expected ranges, and no issues were noted for any other patient samples.No systemic issues have been observed for thcg.The customer believes the original sample may have contained a small clot during the initial testing, or possibly became contaminated after the initial test.The lab has notified the physician's office with a recommendation that the patient be re-drawn for confirmation.The identified issue appears to be isolated to this one patient sample.Based on the available information, a specific cause for the discordance cannot be identified.It is noted that pre-analytical variables can affect sample quality, and deviation from recommended best practices with respect to sample handling can lead to erroneous results.The customer is operational, and the reported issue is resolved by routine troubleshooting.There is no evidence of a reagent or instrument problem.Notes: 1) correction: in section g2, "foreign" had erroneously been selected in the initial report.2) additional information: 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: 20003614
• Report Number: 1219913-2024-00386
• Device Sequence Number: 17995839
• Product Code: DHA
• UDI-Device Identifier: 00630414505152
• UDI-Public: (01)00630414505152(10)09579355(17)240915
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2024

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: 09/15/2024
• Device Model Number: N/A
• Device Catalogue Number: 10308984
• Device Lot Number: 09579355
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/15/2024
• Supplement Date Received by Manufacturer: 08/29/2024
• Initial Report FDA Received Date: 08/20/2024
• Supplement Report FDA Received Date: 09/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2023
• 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: 31 YR
• Patient Sex: Female