MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS CMV IGM; ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS

Catalog Number	07027133190
Medical Device Problem Codes	False Negative Result (1225); High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the e 801 analyzer is (b)(6).The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received questionable results for one patient sample tested with elecsys cmv igg and elecsys cmv igm on a cobas e 801 analytical unit.The results were discrepant from results obtained with a competitor method (abbott alinity).This medwatch will apply to the elecsys cmv igm assay.Please refer to the medwatch with a1.Patient identifier (b)(6) for information related to the elecsys cmv igg assay.The sample was first tested on (b)(6) 2022 using the abbott alinity method, resulting in the following values: cmv igg = 2.5 au/ml (negative).Cmv igm = 9.25 index (positive).The sample was repeated on (b)(6) 2025 using the e 801 analyzer, resulting in the following values: cmv igg = 2.62 u/ml (positive).Cmv igm = 0.42 coi (negative).According to the customer, the patient is a "true" positive for cmv igm and negative for cmv igg.
Additional Manufacturer Narrative
The assays were last calibrated on 16-may-2025 and calibration signals were within expected ranges.A sample specific discrepancy is likely, but further investigations were not possible as the patient's sample was beyond the claimed specimen storage stability.The investigation could 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: 22326946
• Report Number: 1823260-2025-01942
• Device Sequence Number: 21186857
• Product Code: LFZ
• UDI-Device Identifier: 04015630940189
• UDI-Public: 04015630940189
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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): 07/10/2025

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: 828049
• 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: 06/04/2025
• Supplement Date Received by Manufacturer: 07/09/2025
• Initial Report FDA Received Date: 06/25/2025
• Supplement Report FDA Received Date: 07/10/2025
• 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 Sex: Unknown