MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE 2000 XPI BR-MA (CA15-3); SYSTEM, TEST, IMMUNOLOGICAL, ANTIGEN, TUMOR

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	08/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A falsely elevated br-ma (ca15-3) result was obtained on a patient sample on an immulite 2000 xpi instrument.The sample was repeated on an alternate non-siemens instrument.The repeat result was lower than the erroneous result.There are no known reports of patient intervention or adverse health consequences due to the falsely elevated br-ma (ca15-3) result.
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted the siemens customer care center (ccc) to report a falsely elevated br-ma (ca15-3) result that was obtained on a patient sample on an immulite 2000 xpi instrument.The limitation section of the immulite 2000 br-ma (ca15-3) instructions for use (ifu) states: "heterophilic antibodies in human serum can react with the immunoglobulins included in the assay components causing interference with in vitro immunoassays.[see boscato lm, stuart mc.Heterophilic antibodies: a problem for all immunoassays.Clin chem 1988:34: 27-33.] samples from patients routinely exposed to animals or animal serum products can demonstrate this type of interference potentially causing an anomalous result.These reagents have been formulated to minimize the risk of interference; however, potential interactions between rare sera and test components can occur.For diagnostic purposes, the results obtained from this assay should always be used in combination with the clinical examination, patient medical history, and other findings." siemens is investigating.
Additional Manufacturer Narrative
Siemens filed the initial mdr 1219913-2023-00256 on 04-oct-2023.Additional information 05-oct-2023: siemens requested additional information from the customer but did not receive the requested information.Further evaluation is not possible.Based on the information provided in the initial complaint, the root cause could not be identified.A product performance issue has not been identified.No further evaluation of the device is required.In section h6, the investigation findings and investigation conclusions codes were updated.

• Brand Name: IMMULITE 2000 XPI BR-MA (CA15-3)
• Common Device Name: SYSTEM, TEST, IMMUNOLOGICAL, ANTIGEN, TUMOR
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; uk registration #: 3002806944; llanberis, gwynedd LL55 4EL; UK LL55 4EL
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; uk registration #: 3002806944; llanberis, gwynedd LL55 4EL; UK LL55 4EL
• Manufacturer Contact: karen confort ; 333 coney st.; east walpole, MA 02032 ; 3392069063
• MDR Report Key: 17872556
• Report Number: 1219913-2023-00256
• Device Sequence Number: 5953953
• Product Code: MOI
• UDI-Device Identifier: 00630414961088
• UDI-Public: 00630414961088
• Combination Product (Y/N): N
• Initial Reporter Country: MP
• PMA/510(K) Number: K013984
• 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): 10/24/2023

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 Model Number: N/A
• Device Catalogue Number: 10380983
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/13/2023
• Supplement Date Received by Manufacturer: 10/05/2023
• Initial Report FDA Received Date: 10/04/2023
• Supplement Report FDA Received Date: 10/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Unknown