MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM TOTAL HCG (THCG); RADIOIMMUNOASSAY, HUMAN CHORIONIC GONADOTROPIN

Model Number	N/A
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On (b)(6) 2021, the customer observed a patient result of 411.1 miu/ml (positive) when using atellica im thcg, lot 327.The sample was sent to an external laboratory for repeat testing, and produced a <25 miu/ml result.The lower result was considered consistent with the patient's clinical presentation.The instructions for use (ifu) for atellica im 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 obtained an atellica im total hcg (thcg) result of 411.1 miu/ml for one patient which was considered inconsistent with the patient's clinical presentation.Repeat testingusing an alternate method at another laboratory produced a result of <25 miu/ml.There are no allegations of patient harm or changes in treatment resulting from the discordant thcg result.
Additional Manufacturer Narrative
Mdr 1219913-2021-240 was submitted on 04-may-2021 to report observation of a discordant, elevated atellica im total hcg (thcg) result.Siemens healthcare diagnostics has concluded the incident investigation.The customer observed an elevated atellica im total hcg (thcg) result which was discordant relative to alternate-method testing.There were no identified issues with quality control results at the time of the observation, and there were no other similar observations of result discordance, indicating that the instrument and assay were operating properly at the time.Customer instrument log files were not made available for review.Siemens cannot definitively determine the cause of the observed discrepant result.Contributing factors such as sample integrity and/or pre-analytical variables cannot be ruled out.No particular problem indications were identified.The customer is operational and continues to produce and report atellica im thcg results without further concerns.Based on the investigation, no product problem was identified, and it was determined that the atellica im total hcg (thcg) assay is performing as intended.No further action is required.Note: coding for investigation findings and investigation conclusions has been updated in section h6.

• Brand Name: ATELLICA IM TOTAL HCG (THCG)
• Common Device Name: RADIOIMMUNOASSAY, HUMAN CHORIONIC GONADOTROPIN
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 11771217
• Report Number: 1219913-2021-00240
• Device Sequence Number: 17088439
• Product Code: JHI
• UDI-Device Identifier: 00630414600031
• UDI-Public: 00630414600031
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2021

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: 08/06/2021
• Device Model Number: N/A
• Device Catalogue Number: 10995690
• Device Lot Number: 327
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/23/2021
• Supplement Date Received by Manufacturer: 06/22/2021
• Initial Report FDA Received Date: 05/04/2021
• Supplement Report FDA Received Date: 07/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR