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

Model Number	CMV IGG
Medical Device Problem Codes	False Negative Result (1225); Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas e 801 analytical unit serial number is (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of a false negative elecsys cmv igg result from the cobas e 801 analytical unit for one patient.Please see the attachment "(b)(6)" for the patient's results.
Additional Manufacturer Narrative
A new sample was collected from the patient on (b)(6) 2026, and the cmv igg result was <0.25 u/ml (negative).
Additional Manufacturer Narrative
The patient sample was received for investigation.The results of the investigation: elecsys cmv igm: 0.193 coi ->non-reactive.Elecsys cmv igg: 0.150 u/ml (non-reactive.Mikrogen recomline cmv igg: non-reactive.Platelia cmv igg: 0.97 coi ->indeterminate.The non-reactive elecsys cmv igg result was reproducible.Extensive analysis of the patient sample showed that the non-reactive result is supported by immunoblot testing and considered correct.Per product labeling, "elecsys cmv igg results should be used in conjunction with the patient¿s medical history, clinical symptoms and other laboratory tests." 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: 24067106
• Report Number: 1823260-2026-00175
• Device Sequence Number: 9380914
• Product Code: LFZ
• UDI-Device Identifier: 07613336198469
• UDI-Public: 07613336198469
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 04/28/2026

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 Model Number: CMV IGG
• Device Catalogue Number: 09118551190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/24/2025
• Supplement Date Received by Manufacturer: 01/29/2026; 04/08/2026
• Initial Report FDA Received Date: 01/14/2026
• Supplement Report FDA Received Date: 02/20/2026; 04/28/2026
• 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: 32 YR
• Patient Sex: Female