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	07/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable elecsys cmv igm assay results for a patient sample tested on the cobas e 801 module.On (b)(6) 2025: elecsys cmv igm result was 0.58 coi (non-reactive).Elecsys cmv igg result was 24.4 u/ml (reactive).On (b)(6) 2025: vidas cmv igg result was 25 au/ml (reactive).Vidas cmv igg avidity result was 40 avi% (equivocal).Diasorin liaison cmv igm result was 32.7 au/ml (reactive).Diasorin liaison cmv igg result was 69.8 au/ml (reactive) diasorin liaison cmv igg avidity result was 0.199.On (b)(6) 2025: elecsys cmv igm result was 0.54 coi (non-reactive).Elecsys cmv igg result was 21.3 u/ml (reactive).
Additional Manufacturer Narrative
The serial number of the analyzer was (b)(6).The remaining sample volume was sent to another laboratory for additional testing.The investigation is ongoing.
Additional Manufacturer Narrative
Qc and calibration data were found to be within the expected ranges.No further results were provided from the additional testing performed at the other laboratory.Sample material was requested; however, no sample volume was left.Therefore, further investigation could not be performed.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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: 23556199
• Report Number: 1823260-2025-04643
• Device Sequence Number: 10053099
• Product Code: LFZ
• UDI-Device Identifier: 04015630940189
• UDI-Public: 04015630940189
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 12/03/2025

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: 01/31/2026
• Device Catalogue Number: 07027133190
• Device Lot Number: 848029
• 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: 10/21/2025
• Supplement Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 11/14/2025
• Supplement Report FDA Received Date: 12/03/2025
• 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: 39 YR
• Patient Sex: Female