MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS CMV IGG; CYTOMEGALOVIRUS IMMUNOASSAY

Model Number	CMV IGG
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The e801 analyzer serial number was (b)(6).The patient sample was requested for investigation.
Event or Problem Description
The initial reporter questioned a high result for 1 patient sample tested for elecsys cmv igg (cmv igg) on a cobas e 801 analytical unit.The initial cmv igg result from the e801 analyzer was 12.1 u/ml (positive).For confirmation, the sample was sent to 2 external laboratories, where the cmv igg results from 3 competitor methods were: abbott alinity: < 6 (unit of measure not provided); negative.Diasorin liaison: < 5 (unit of measure not provided); negative.Vidas biomérieux: < 4 (unit of measure not provided); negative.On (b)(6) 2025, the sample was repeated on the e801 analyzer, and the result was "positive." the specific result was not provided.
Additional Manufacturer Narrative
Calibration and qc were acceptable.The patient sample was submitted for investigation.The customer's positive cmv igg results were reproduced at the investigation site (13.6 u/ml, positive).The sample was also tested for elecsys cmv igm (0.239 coi, negative) and elecsys cmv igg avidity (98.1 avi%, high).The sample was tested further with other methods: platelia cmv igg (0.2 iu/ml, negative) and mikrogen recomline cmv igg (negative).The results produced during the investigation suggest the elecsys results are false positives caused by a systemically interfering compound.Product labeling states: "interference due to extremely high titers of antibodies to immunological components, streptavidin or ruthenium can occur.These effects are minimized by suitable test design." for diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination, and other findings.The investigation did not identify a product problem.

• Brand Name: ELECSYS CMV IGG
• Common Device Name: CYTOMEGALOVIRUS IMMUNOASSAY
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 23706928
• Report Number: 1823260-2025-04931
• Device Sequence Number: 13429433
• Product Code: LFZ
• UDI-Device Identifier: 07613336198469
• UDI-Public: 07613336198469
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K220911
• 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): 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: 06/30/2026
• Device Model Number: CMV IGG
• Device Catalogue Number: 09118551190
• Device Lot Number: 878438
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/17/2025
• Supplement Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 04/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sequence Number: 1
• Patient Age: 33 YR
• Patient Sex: Female