MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR TOTAL HCG ASSAY; RADIOIMMUNOASSAY, HUMAN CHORIONIC GONADOTROPIN

Model Number	N/A
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On (b)(6) 2021, the customer observed three patient results of 2.0 miu/ml (negative) when using advia centaur xpt thcg, lot 326.The samples were repeat-tested on the advia centaur xpt, and produced positive results.These same patients were tested again using an alternate method, and yielded positive results.The positive hcg results were accepted as correct.Assay quality controls were within range, and no instrument issues were observed or indicated in logs.The instructions for use (ifu) for advia centaur thcg states the following, under interpretation of results: "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 observed advia centaur xpt total hcg (thcg) results for 3 patients which were identified as falsely-depressed relative to repeat testing using the same method and an alternate method.There are no known reports of patient intervention or adverse health consequences due to the discordant thcg results.
Additional Manufacturer Narrative
Mdr 1219913-2021-00112 was filed on 18-feb-2021 to report three low discordant patient results observed when using advia centaur xpt total hcg (thcg), lot 326.Additional information, 05-mar-2021: siemens has concluded the incident investigation.The customer observed three low discordant thcg patient results on (b)(6) 2021.The initial results were <2 miu/ml; repeat-testing results were significantly higher.The higher values were reported as clinically accurate.All quality control results were within range and no system errors were identified on the day of the event.The customer also tested the three samples using an alternate method and the results were positive.Service investigated the issue at the customer site on 15-feb-2021.No instrument issues were identified, but the engineer tested the system by running dark counts (background measurements) and precision studies.Thcg quality controls and patient samples were run in replicates of 5, and observed precision met manufacturer's guidelines.Siemens cannot definitively determine the cause of this discrepant result.Contributing factors such as sample integrity or an isolated instrument event cannot be ruled out.Repeat testing of the same samples yielded expected results.The customer has monitored thcg performance and has no further concerns.A potential product issue has not been identified.The customer is operational.No further evaluation of the device is required.Note: in section h6, the investigation findings and investigation conclusion codes were added.

• Brand Name: ADVIA CENTAUR TOTAL HCG ASSAY
• Common Device Name: RADIOIMMUNOASSAY, HUMAN CHORIONIC GONADOTROPIN
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 11343901
• Report Number: 1219913-2021-00112
• Device Sequence Number: 4831880
• Product Code: JHI
• UDI-Device Identifier: 00630414505176
• UDI-Public: 00630414505176
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K925277
• 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 faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2021

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: No Information
• Device Expiration Date: 08/06/2021
• Device Model Number: N/A
• Device Catalogue Number: 10308985
• Device Lot Number: 326
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/12/2021
• Supplement Date Received by Manufacturer: 03/05/2021
• Initial Report FDA Received Date: 02/18/2021
• Supplement Report FDA Received Date: 03/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1