MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS ATELLICA IM TOTAL HCG; THCG ASSAY

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	04/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer obtained a total human chorionic gonadotropin (thcg) low result on a female patient, on atellica im module.The initial result was not reported to the physician(s).After failing controls in this atellica im module, an impact analysis was performed, with repetition of the sample on other atellica im modules.The repeat results were elevated compared to the initial result.The same sample was again repeated on the initial atellica im module in triplicate, and the results were comparable to the elevated results.A new sample from the same patient was measured on two atellica im modules and the results were low and similar to the initial result.This sample was also repeated on the initial atellica im module and the result remained low.The lower results were considered as correct by the physician(s).There are no allegations of patient harm, changes in treatment, or delays in diagnosis in association with the discordant atellica im elevated thcg results.
Additional Manufacturer Narrative
An outside the united states customer obtained a total human chorionic gonadotropin (thcg) low result on a female patient, on atellica im module.The initial result was not reported to the physician(s).After failing controls in this atellica im module, an impact analysis was performed, with repetition of the sample on other atellica im modules.The repeat results were elevated compared to the initial result.The same sample was again repeated on the initial atellica im module in triplicate, and the results were comparable to the elevated results.A new sample from the same patient was measured on two atellica im modules and the results were low and similar to the initial result.This sample was also repeated on the initial atellica im module and the result remained low.The lower results were considered as correct by the physician(s).Calibration and qc (quality controls) for thcg results were within specifications.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." mdr 1219913-2023-00120 and mdr 1219913-2023-00125 were filed for different updates of the event.Siemens healthcare diagnostics is investigating.
Additional Manufacturer Narrative
Siemens filed the initial mdr 1219913-2023-00126 on may 11, 2023.Additional information jun 09, 2023: an outside the united states customer obtained a total human chorionic gonadotropin (thcg) low result (<2.00 miu/ml) on a female patient, on atellica im module (s/n (b)(6)), lot 344 on (b)(6) 2023.The initial result was not reported to the physician(s).After failing controls in this atellica im module, an impact analysis was performed, with repetition of the sample on other atellica im modules.The repeat results were elevated compared to the initial result.The same sample was again repeated on the initial atellica im module in triplicate, and the results were comparable to the elevated results.A new sample from the same patient was measured on two atellica im modules and the results were low and similar to the initial result.This sample was also repeated on the initial atellica im module and the result remained low.The lower results were considered as correct by the physician(s).Total human chorionic gonadotropin (thcg) calibration and qc (quality controls) were within specifications for all repeat testing.Based on the available information, cause of the discordant result is consistent with samples handling and/or integrity issue isolated to just one sample.A potential product issue has not been identified.The customer is operational.Mdr 1219913-2023-00120 supplemental 1 and mdr 1219913-2023-00125 supplemental 1 were filed for the same updates.

• Brand Name: ATELLICA IM TOTAL HCG
• Common Device Name: THCG ASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown NY 10591 5097
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC; 333 coney street; east walpole MA 02032
• Manufacturer Contact: louise mclaughlin ; 333 coney street; east walpole, MA 02032 ; 7818564812
• MDR Report Key: 16912255
• Report Number: 1219913-2023-00126
• Device Sequence Number: 2381648
• Product Code: JHI
• UDI-Device Identifier: 00630414600024
• UDI-Public: 00630414600024
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/14/2023
• Device Model Number: N/A
• Device Catalogue Number: 10995689
• Device Lot Number: 344
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/17/2023
• Supplement Date Received by Manufacturer: 06/09/2023
• Initial Report FDA Received Date: 05/11/2023
• Supplement Report FDA Received Date: 07/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2022
• 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: 32 YR
• Patient Sex: Female