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

Device Problem High Test Results (2457)

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

Event Date 08/21/2023

Event Type  malfunction  

Event 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.

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.

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)
• Type of Device: 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
• MDR Text Key: 325380282
• Report Number: 1219913-2023-00256
• Device Sequence Number: 1
• Product Code: MOI
• UDI-Device Identifier: 00630414961088
• UDI-Public: 00630414961088
• Combination Product (y/n): N
• Reporter Country Code: MP
• PMA/PMN Number: K013984
• 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: 10/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 10/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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