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	09/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The e402 analyzer serial number was (b)(6).Calibration was last performed on (b)(6) 2025 with no issues.Qc was acceptable.
Event or Problem Description
The initial reporter complained of a false negative result for 1 patient sample tested for elecsys cmv igm (cmv igm) on a cobas e 402 analytical unit.The result from the e402 analyzer was 0.290 coi (negative).The result from an unspecified enzyme-linked fluorescent assay (elfa) method was "borderline." the specific result was not provided.The dna blood test result was "negative." the urine test was "positive.".
Additional Manufacturer Narrative
It was clarified that the unspecified enzyme-linked fluorescent assay (elfa) method was the vidas method.Sample material was requested for investigation.
Additional Manufacturer Narrative
Sample material from the patient was submitted for investigation.The non-reactive elecsys cmv igm result was reproduced.Extensive analysis of the patient sample revealed that the elecsys result was supported by other methods (platelia cmv igm and mikrogen recomline cmv igm) and was considered to be correct.The scenario is consistent with the patient in the late convalescent phase of a primary infection, which is in accordance with the findings obtained with pcr.No product problem was found.

• 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: 23288013
• Report Number: 1823260-2025-04184
• Device Sequence Number: 5506815
• Product Code: LFZ
• UDI-Device Identifier: 04015630940189
• UDI-Public: 04015630940189
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,Followup
• Report Date (Section B): 01/13/2026

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: 04/30/2026
• Device Catalogue Number: 07027133190
• Device Lot Number: 86838401
• 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: 09/22/2025
• Supplement Date Received by Manufacturer: 10/14/2025; 12/22/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 11/04/2025; 01/13/2026
• 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