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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable elecsys cmv igm results for 1 patient sample on an unknown cobas analyzer compared to a competitor analyzer.The roche result was negative.The sample was tested on a vidas analyzer and the result was positive.
Additional Manufacturer Narrative
The analyzer serial number was not provided.The investigation is ongoing.
Additional Manufacturer Narrative
On (b)(6) 2025, specific results were provided for 3 separate samples from the patient.On (b)(6) 2025, the cmv igm result was negative.The sample was tested on a vidas analyzer and the cmv igm result was positive.On (b)(6) 2025, the cmv igm result was negative.The sample was tested on a vidas analyzer and the cmv igm result was positive.A third sample was collected 3 weeks later and the cmv igm result was negative.The investigation determined that the results provided are indicative of an early cmv infection.Individuals at the early stage of acute infection may not exhibit detectable amounts of cmv igm antibodies.In some individuals, a borderline or low positive result with the elecsys cmv igg assay may be found and indicate an early acute infection.A second sample should be tested within 2-3 weeks.The detection of cmv igm and/or a significant increase of the elecsys cmv igg antibody titer in the second sample supports the diagnosis of an acute cmv infection.The investigation did not identify a product problem.The elecsys cmv igm assay performs within specification.

• Brand Name: ELECSYS CMV IGM
• Common Device Name: ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS
• 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: 23619401
• Report Number: 1823260-2025-04781
• Device Sequence Number: 10090454
• Product Code: LFZ
• UDI-Device Identifier: 04015630940189
• UDI-Public: 04015630940189
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K142133
• 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): 02/03/2026

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 Catalogue Number: 07027133190
• 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: 11/03/2025
• Supplement Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 02/03/2026
• 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: 34 YR
• Patient Sex: Female