MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM TOTAL HCG (THCG)

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	09/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted the customer care center (ccc) and reported high quality control results and discordant patient results using the atellica im total hcg assay, lot 334 compared to lot 329.The results were not questioned by the physician(s).The limitations section of the instructions for use (ifu) states the following: "all in vitro assays can generate erroneous results, both clinically false positive results (test results suggesting a condition that is absent) and clinically false negative results (test results failing to identify a condition that is present).There are many possible causes for these types of discordant results.Erroneous results may occur due to interference from identifiable serum constituents or patient-specific serum constituents." "if an aberrant or abnormal result, as defined by the laboratory protocol, occurs, laboratory personnel should first make certain that the system is performing and is operated and maintained in accordance with the product labeling.The user should then follow the laboratory protocol for advising the clinician of a result that appears to have deviated from the norms established by the laboratory.Test results alone are not diagnoses of medical conditions.For example, low titer elevations of hcg can occur in normal non-pregnant subjects.A physician's diagnosis involves evaluation of the test result in conjunction with, and in the context of, the patient's medical history, physical examination, and other test results sometimes in consultation with other medical experts." siemens has completed the investigation.The customer observed a high bias when moving from atellica im total hcg (thcg) reagent lot 329 to 334.The customers data for biorad immunoassay plus qc lot 85220 shows a slight negative bias on lot 329 and slight positive bias on 334.Qc recovers within biorad insert ranges on both reagent lots.The customer compared results for patient samples tested on reagent lots 329 and 334 showing an average bias of ~20%.These samples were not tested side by side and did not span the assay range.Siemens has reviewed internal patient sample comparison data for atellica im thcg reagent lot 332 vs.334, this shows an average bias of 3.06% between these lots.Review of reagent release data for lot 334 shows that all internal acceptance criteria was met.A search of the complaint handling database for thcg lot 334 did not show any similar escalations.The local team has now followed up with the customer and they have recalibrated lot 334 and their qc is within the laboratory's established ranges.The customer is now running thcg reagent lot 334 and has no further concerns.A potential product performance issue has not been identified.Atellica im thcg reagent lot 334 is working as specified.
Event or Problem Description
The customer reported that with the calibration of the new atellica im total hcg (thcg) reagent lot 334 and new calibrator cb 099, high quality control results and discordant patient results were observed with lot 334 compared to lot 329.The results for reagent lot 334 were reported to the physician(s), but not questioned.There are no known reports of patient intervention or adverse health consequences due to the discordant, total hcg, results.

• Brand Name: ATELLICA IM TOTAL HCG (THCG)
• Common Device Name: ATELLICA IM TOTAL HCG (THCG)
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 12590444
• Report Number: 1219913-2021-00459
• Device Sequence Number: 19655604
• Product Code: JHI
• UDI-Device Identifier: 00630414600031
• UDI-Public: 00630414600031
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K172322
• 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,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/07/2021

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: Health Professional
• Device Expiration Date: 04/04/2022
• Device Model Number: N/A
• Device Catalogue Number: 10995690
• Device Lot Number: 334
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/07/2021
• Initial Report FDA Received Date: 10/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1