MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE 2000 OM-MA; TEST, EPITHELIAL OVARIAN TUMOR-ASSOCIATED ANTIGEN (CA125)

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	03/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states customer contacted a siemens regional support center to report the observation of a discordant elevated om-ma (ov) patient result when using kit lot 321 on an immulite 2000 xpi instrument.The adjustment was valid and quality control results were within acceptable ranges on the date of testing.The limitations section for the immulite 2000 om-ma instructions for use states "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.
Event or Problem Description
The customer reported the observation of a discordant elevated om-ma (ov) patient result when using kit lot 321 on an immulite 2000 xpi instrument.The initial result was reported to and questioned by the physician(s).The sample was repeated on the initial instrument, and the repeat result was lower, and reported as the correct result, to the physician(s).There are no known reports of patient intervention or adverse health consequences due to this issue.
Additional Manufacturer Narrative
Siemens filed the initial mdr 1219913-2026-00061 on 24-mar-2026.Additional information 01-apr-2026 siemens evaluated this issue and provided the following conclusion: siemens healthineers reviewed the complaint for a discordant patient result when using om-ma (ov) lot 321 on an immulite 2000 xpi instrument.The adjustment performed on 25-feb-2026 was within specification and quality control results were within acceptable ranges on the date the discordant result was obtained.A siemens customer service engineer (cse) was dispatched to the customer site and performed the following routine service actions: checked sample and reagent probe alignments and dispense, verified sample probe clot detection, confirmed no leaks present in valve manifolds, primed dual resolution dilutors (drd), verified vacuum pressure, cleaned wash station, cleaned wash spinner, and verified luminometer performance.Following these actions, the cse performed a precision test, and results were within the customer's range for acceptable % cv.The customer is operational running the om-ma (ov) assay on the immulite 2000 xpi instrument.Based on the available information, a sample integrity issue cannot be ruled out as probable cause of the observed behavior.Immulite 2000 om-ma (ov) lot 321 is performing as intended.A product performance issue has not been identified.No further evaluation of the device is required.In section h6, the investigation findings and investigation conclusion codes were updated.

• Brand Name: IMMULITE 2000 OM-MA
• Common Device Name: TEST, EPITHELIAL OVARIAN TUMOR-ASSOCIATED ANTIGEN (CA125)
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy, gwynedd; uk registration # 3002806944; llanberis LL554 EL; UK LL554EL
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy, gwynedd; uk registration # 3002806944; llanberis LL554 EL; UK LL554EL
• Manufacturer Contact: jennifer cacace ; 333 coney street; east walpole, MA 02032 ; 8024302902
• MDR Report Key: 24681026
• Report Number: 1219913-2026-00061
• Device Sequence Number: 9770860
• Product Code: LTK
• UDI-Device Identifier: 00630414961798
• UDI-Public: (01)00630414961798(10)321(17)260702
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K213510
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2026

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: 07/02/2026
• Device Model Number: N/A
• Device Catalogue Number: 10380972
• Device Lot Number: 321
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2026
• Supplement Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 03/24/2026
• Supplement Report FDA Received Date: 04/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/02/2025
• 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