MAUDE Adverse Event Report: Roche Diagnostics Elecsys CMV IgM; ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS

Catalog Number	07027133190
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Codes	Neonatal Hearing Impairment (1975); Insufficient Information (4580)
Date of Event	11/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
We received an allegation about discrepant results for 2 samples from the same patient tested with elecsys cmv igm assay on a cobas e 801 analytical unit.The pregnant patient was tested using the liaison method: on (b)(6)2025, the cmv igm result was 63 ua/ml (positive).On (b)(6)2025, the cmv igm result was 61 ua/ml (positive).It was alleged that on (b)(6)2025, the elecsys cmv igm result was 0.68 coi, and on (b)(6)2025, the elecsys cmv igm result was 0.69 coi, and both results were considered non¿reactive.On (b)(6) 2025, the patient was tested using the liaison method, and the cmv igm result was 29 ua/ml (positive).Allegedly, the baby was tested with urine cmv pcr, and the result was 7.34 iu/ml (positive).Reportedly, it was alleged that the baby is receiving unspecified treatment and has hearing loss.This mdr is being submitted in an abundance of caution.
Additional Manufacturer Narrative
The elecsys cmv igm reagent expiration date was not provided.The cobas e 801 analytical unit serial number was (b)(6).The qc was acceptable.The investigation is ongoing.

• Brand Name: Elecsys CMV IgM
• Common Device Name: ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS
• 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: 50052864
• Report Number: 1823260-2026-03018
• Device Sequence Number: 10639797
• Product Code: LFZ
• UDI-Device Identifier: 04015630940189
• UDI-Public: 04015630940189
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K142133
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 08/31/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 07027133190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/01/2026
• Supplement Date Received by Manufacturer: 08/06/2026
• Initial Report FDA Received Date: 07/28/2026
• Supplement Report FDA Received Date: 08/31/2026
• 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
• Outcome Attributed to Adverse Event: Congenital Anomaly
• Patient Sex: Unknown