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	04/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer notified siemens of discordant results when testing a patient sample with advia centaur cp total hcg (thcg) lot 357.The patient sample was tested in duplicate.The replicates were discordant from each other, and the lower (negative) result was believed to be accurate based on the patient's clinical history.There are no allegations of patient or user intervention or adverse health consequences due to the event.
Additional Manufacturer Narrative
A united states (ous) customer contacted the siemens customer care center to report discordant results when testing a patient sample with advia centaur cp total hcg (thcg) lot 357.Siemens is investigating.
Additional Manufacturer Narrative
Siemens filed mdr 1219913-2024-00306 initial report with the fda on 16-may-2024.Siemens has concluded the investigation for a united states customer who obtained falsely elevated results for a patient on the advia centaur cp total hcg (thcg) assay with reagent lot 357.The customer expected (negative) results based on the patient's clinical history (not pregnant, day 3 of menstrual cycle).Siemens reviewed quality control (qc) results, which showed recovery within acceptable ranges.When the system was visually inspected by a siemens customer service engineer (cse), an observation was made that fluid was intermittently dripping back into cuvettes at the wash station.The cse replaced parts and the system was then primed, and fluid was no longer seen dripping at the wash station.The instrument was re-calibrated, and qc and precision were tested and found to be acceptable following service.The customer has monitored the analyzer and performance remains acceptable.A product problem was not identified.The customer is operational, and the reported issue was resolved by service part replacement.A product problem was not identified.In section h6 of this report, the investigation finding and conclusion codes were updated based on the investigation results.Corrections: 1.Section b6 of mdr 1219913-2024-00306 initial report filed 16-may-2024 incorrectly identifies the result of 1.5 miu/ml as correct, but it should be identified as discordant.Both results listed were considered erroneous as the patient was on day 3 of her menstrual cycle who was not pregnant, therefore results should have been < 0.6 miu/ml.2.Section h10 of mdr 1219913-2024-00306 initial report filed 16-may-2024 contains a typographical error where the statement "a united states (ous) customer contacted the siemens customer care center to report discordant results when testing a patient sample with advia centaur cp total hcg (thcg) lot 357." should read, "a united states (us) customer." c.

• 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 10591
• Manufacturer Contact: stacy loukos ; 333 coney st.; east walpole, MA 02032
• MDR Report Key: 19327727
• Report Number: 1219913-2024-00306
• Device Sequence Number: 6816114
• Product Code: DHA
• UDI-Device Identifier: 00630414505152
• UDI-Public: 00630414505152
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K192790
• 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): 05/24/2024

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: 10308984
• Device Lot Number: 357
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/16/2024
• Supplement Date Received by Manufacturer: 05/16/2024
• Initial Report FDA Received Date: 05/15/2024
• Supplement Report FDA Received Date: 05/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 34 YR
• Patient Sex: Female