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	09/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation about discrepant results for 1 patient sample tested with elecsys cmv igm assay on a cobas e 801 analytical unit.Initial result: 0.337 coi and interpreted as non-reactive.On (b)(6) 2025: the sample was tested, and the result was 0.326 coi and interpreted as negative.The sample was sent to a reference laboratory using the chemiluminescence method and repeated.The 1st repeat result was 56.1 and interpreted as positive.The unit of measurement was not provided.This result was reported.The sample was then repeated using the enzyme-linked fluorescence assay (elfa) method on a diasorin liaison instrument, and the 2nd repeat result was positive.On (b)(6) 2025: the sample was tested after performing qc, and the result was 0.316 coi and interpreted as non-reactive.No questionable result was reported outside the laboratory.
Additional Manufacturer Narrative
The cobas e 801 analytical unit serial number was (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
Section b7 was updated.One sample was received for investigation on 06-nov-2025.The investigation is ongoing.
Additional Manufacturer Narrative
The calibration and qc results were within the expected ranges.The sample was received for investigation on 06-nov-2025, and was tested using the elecsys assays and competitor assays: elecsys cmv igm assay: 0.307 coi (non-reactive).Elecsys cmv igg assay: 0.701 u/ml (borderline).Platelia cmv igm assay: 0.89 coi (borderline).Mikrogen recomline cmv igm assay: non-reactive mikrogen recomline cmv igg assay: non-reactive.The investigation confirmed the customer's elecsys cmv igm results.The elecsys cmv igm assay result was supported by the results of competitor assays and was considered correct.The investigation determined that the patient may have had a very early cytomegalovirus (cmv) infection, or the observed reactive cmv igm results were caused by cross-reactivity, possibly due to epstein-barr virus (ebv) infection.The investigation did not identify a product problem.

• 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: 23278151
• Report Number: 1823260-2025-04166
• Device Sequence Number: 8854317
• 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): 01/19/2026

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: 868384
• 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: 09/17/2025
• Supplement Date Received by Manufacturer: 10/14/2025; 01/02/2026
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 11/07/2025; 01/19/2026
• 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: Unknown