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

Model Number N/A

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/12/2022

Event Type  malfunction  

Manufacturer Narrative

A customer from outside the united states reports observation of a falsely-depressed atellica im total hcg (thcg) result for one patient which was discordant relative to repeat testing.The initial result was reported to the physician, and questioned.Repeat testing of the patient, using new and original samples, produced higher results, which were accepted as correct.The interpretation of results section of the atellica im thcg instructions for use states: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings." siemens is investigating.

Event Description

The customer reports observation of a falsely-depressed atellica im total hcg (thcg) result for one patient which was discordant relative to repeat testing.The initial result was reported to the physician, and questioned.Repeat testing of the patient, using new and original samples, produced higher results, which were accepted as correct.There are no allegations of patient harm, changes in treatment, or delays in diagnosis in association with the discordant atellica im thcg result.

Manufacturer Narrative

Mdr 1219913-2022-00382 was initially filed on 2022-11-3.Additional information, 2023-01-27: siemens has concluded the investigation.A customer from outside the united states reported observation of a falsely-depressed atellica im total hcg (thcg) result for one patient which was discordant relative to repeat testing.On 2022 (b)(6), an initial thcg result of 3.9 iu/l was obtained, and considered lower than expected.The same sample was re-tested on 2022 (b)(6), and produced a much higher thcg result of 1,873 iu/l.A new sample was drawn and tested on 2022 (b)(6), and it produced a result much higher than the assay's reference interval.The higher results were accepted as clinically correct.Quality control results for this assay were within range on both days of testing.Other samples tested for thcg at this time were not questioned.The customer has not expressed any additional concerns with the thcg assay.Siemens did not receive complete trace-file data from the associated atellica im analyzer, so records for instrument reagent handling could not be fully examined.Siemens cannot definitively identify the cause for the observed discordant result, but pre-analytical factors and sample handling issues cannot be ruled out.Based on the investigation, no product problem was identified.Note: in section h6, the codes for investigation findings and investigation conclusion have been updated.

• Brand Name: ATELLICA IM TOTAL HCG (THCG)
• Type of Device: THCG ASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 333 coney street; east walpole MA 02032
• Manufacturer Contact: barry ; 333 coney street; east walpole, MA 02032 ; 5082985306
• MDR Report Key: 15730460
• MDR Text Key: 305105813
• Report Number: 1219913-2022-00382
• Device Sequence Number: 1
• Product Code: JHI
• UDI-Device Identifier: 00630414600024
• UDI-Public: 00630414600024
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K172322
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/07/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 01/11/2023
• Device Model Number: N/A
• Device Catalogue Number: 10995689
• Device Lot Number: 340
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/30/2022
• Initial Date FDA Received: 11/04/2022
• Supplement Dates Manufacturer Received: 01/27/2023
• Supplement Dates FDA Received: 02/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female