MAUDE Adverse Event Report: Roche Diagnostics Elecsys CMV IgG; Cytomegalovirus Immunoassay

Model Number	CMV IgG
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable elecsys cmv igg and elecsys cmv igm results for 1 patient on a cobas e 801 analytical unit compared to a vidas analyzer.This medwatch will cover cmv igg.Refer to medwatch with a1 patient identifier (b)(6) for information on the cmv igm results.On (b)(6) 2025, the patient had a cmv igg result of 0.38 u/ml (negative) and a cmv igm result of 0.69 coi (negative).On (b)(6) 2026, the patient had a cmv igg result of 3.68 u/ml (positive) and a cmv igm result of 0.657 coi (negative).On (b)(6) 2026, the customer repeated the previous patient samples.The sample from on (b)(6) 2025 gave a cmv igg result of 0.37 u/ml (negative) and a cmv igm result of 0.789 coi (equivocal).The sample was also sent to another laboratory and tested on a vidas analyzer and the cmv igg result was 20 (positive) and the cmv igm result was 33.6 (positive).The sample from on (b)(6) 2026 gave a cmv igg result of 3.69 u/ml (positive) and a cmv igm result of 0.718 coi (equivocal).The sample was also sent to another laboratory and tested on a vidas analyzer and the cmv igg result was 19 (positive) and the cmv igm result was 24 (positive).The vidas analyzer results units of measurement were not provided.
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The investigation is ongoing.

• Brand Name: Elecsys CMV IgG
• Common Device Name: Cytomegalovirus Immunoassay
• Manufacturer (Section D): Roche Diagnostics; 9115 hague road; indianapolis IN 46250 -045
• 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: 50224800
• Report Number: 1823260-2026-03307
• Device Sequence Number: 5482196
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/12/2026

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: 87843801
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/16/2026
• Initial Report FDA Received Date: 08/12/2026
• 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: Female