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

Model Number	CMV IGG
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas e 801 analytical unit serial number was (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable elecsys cmv igg results from the cobas e 801 analytical unit.Patient 1 initial cmv igg result was 12 coi (reactive).Patient 2 initial cmv igg result was 3.5 coi (reactive).Both samples were retested on a different instrument (chorus evo diesse, elisa method), due to a previous negative cmv igg history for both patients.The results obtained on the elisa system were negative: patient 1: < 0.20, patient 2: < 0.20.Following this, a rerun was performed on the original cobas instrument after recalibration: patient 1: cmv igg = 12 coi (reactive).Patient 2: cmv igg = 3.5 coi (reactive).
Additional Manufacturer Narrative
The customer alleged false reactive elecsys cmv igg results for three additional patient samples.On (b)(6) 2025, sample 3 cmv igg result was 12.1 u/ml(reactive).The result by risultati chorus trio was 0.71 iu/ml.On (b)(6) 2025, sample 4 cmv igg result was 2.75 u/ml(reactive).The result by risultati chorus trio was <0.5 iu/ml.On (b)(6) 2025, sample 5 cmv igg result was 12.4 u/ml(reactive).The repeat result was not provided.Sample material from the five involved samples was requested for further investigation.
Additional Manufacturer Narrative
Medwatch field d4 expiration date was updated.Samples for the first 3 patients were received for investigation.The customer¿s reactive results with elecsys cmv igg were reproducible for all 3 samples.Further analysis determined that the elecsys results for patients 1 and 3 were considered correctly positive.The result for patient sample 2 was likely a false positive with the elecsys cmv igg assay.The result was discordant to all methods tested and showed a uniform distribution of antigen reactivity.This is consistent with an interfering compound in the sample.A general product problem or malfunction was not found.

• 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: 23310267
• Report Number: 1823260-2025-04220
• Device Sequence Number: 20080756
• Product Code: LFZ
• UDI-Device Identifier: 07613336198469
• UDI-Public: 07613336198469
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,Followup
• Report Date (Section B): 03/20/2026

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: 03/31/2026
• Device Model Number: CMV IGG
• Device Catalogue Number: 09118551190
• Device Lot Number: 8663613
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/25/2025
• Supplement Date Received by Manufacturer: 10/17/2025; 03/02/2026
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 11/06/2025; 03/20/2026
• 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 Sex: Unknown