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

Model Number N/A

Device Problem High Test Results (2457)

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

Event Date 01/16/2023

Event Type  malfunction  

Manufacturer Narrative

An outside the united states customer obtained a discordant elevated atellica im total hcg result for one patient.The sample was remeasured on another atellica im system, and the result was same.Repeat testing was done on alternate methods - all negative for total hcg.The interpretation of results section of the atellica im total hcg 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 continues to investigate.Mdr 1219913-2023-00027 were filed for the same event.

Event Description

The customer obtained a discordant elevated atellica im total hcg result for one patient.The sample was remeasured on another atellica im system, and the result was same.Repeat testing was done on alternate methods - all negative for total hcg.There are no reports that treatment was altered or prescribed or adverse health consequences due to the discordant atellica im total hcg result.

Manufacturer Narrative

Initial mdr 1219913-2023-00026 was filed on feb 09, 2023 reporting a customer from outside the united states obtained a discordant elevated atellica im total hcg result for one patient.The sample was remeasured on another atellica im system, and the result was the same.Repeat testing was done on alternate methods; all were negative for total hcg.Additional information - may 10, 2023 the returned patient sample was tested on the atellica im thcg assay (with lots 344 and 346) and on the immulite 2000 hcg assay (with lot 475).Calibrations were valid, and biorad immunoassay plus quality control (qc) lot 85320 recovered within insert ranges prior to testing the patient samples.Returned sample (id# (b)(6)): atellica im thcg lot 344= 10 miu/ml atellica im thcg lot 346= 9.2 miu/ml immulite 2000 hcg lot 475= 1.22 miu/ml the returned patient sample was treated with heterophilic blocking tubes (hbt) and retested on the atellica im thcg assay.The thcg results following hbt decreased to <1 miu/ml.As stated in the atellica im thcg instructions for use limitation section: "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.Erroneous results due to interference are repeatable over time.Persistent serum hcg results in the range of 10.0-100.0 miu/ml (more typically 10.0-50.0 miu/ml) over several months suggest that the patient's blood may contain an interfering substance and produce erroneous results.Identified sources of interference that have the potential to bind to and interfere with any component of the assay include plasma components (clotting factors), serum proteins (such as rheumatoid factor), and anti-idiotype antibodies.Interference can also be caused by drugs and drug metabolites, and cross-reacting substances.Patient samples may contain heterophilic antibodies that could react in immunoassays to give falsely elevated or depressed results.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 labelling.Test results alone are not diagnostics of medical conditions.For example, low titer elevations of hcg can occur in normal, non-pregnant subjects.A physician's diagnosis involves the 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." based on the available information, the cause of the discordant result is consistent with a sample specific interferent.No potential product issue is observed.The customer is operational.In section h6, the investigation finding and investigation conclusion codes were updated.Mdr 1219913-2023-00026 supplemental 1 and 1219913-2023-00027 supplemental 1 were filed for the same event.

• Brand Name: ATELLICA IM TOTAL HCG (THCG) ASSAY
• Type of Device: TOTAL HCG (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: louise mclaughlin ; 333 coney street; east walpole, MA 02032 ; 7818564812
• MDR Report Key: 16334266
• MDR Text Key: 309158006
• Report Number: 1219913-2023-00026
• Device Sequence Number: 1
• Product Code: JHI
• UDI-Device Identifier: 00630414600031
• UDI-Public: 00630414600031
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 06/01/2023

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: 05/14/2023
• Device Model Number: N/A
• Device Catalogue Number: 10995690
• Device Lot Number: 344
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/01/2023
• Initial Date FDA Received: 02/09/2023
• Supplement Dates Manufacturer Received: 05/10/2023
• Supplement Dates FDA Received: 06/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2022
• 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 Age: 24 YR
• Patient Sex: Female