MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS CMV IGG; CYTOMEGALOVIRUS IMMUNOASSAY

Model Number	CMV IGG
Medical Device Problem Code	Low Test Results (2458)
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 e801 analyzer serial number was (b)(6).
Event or Problem Description
The initial reporter questioned the results from multiple samples from 1 patient tested for elecsys cmv igg (cmv igg) on a cobas e 801 analytical unit.Sample from (b)(6) 2025: the cmv igg result from the e801 analyzer was 0.61 u/ml (borderline).This sample was tested by 2 competitor methods: diasorin liaison cmv igg: 20.4 au/ml (positive) diasorin liaison cmv igg avidity: igg too low (avidity not interpretable) biomérieux vidas cmv igg: 9 au/ml (positive) biomérieux vidas cmv igg avidity: 8 avi% the results suggest a recent primary cmv infection.Sample from (b)(6) 2025: the cmv igg result from the e801 analyzer was 0.276 u/ml (negative).Sample from (b)(6) 2025: on (b)(6) 2025, the cmv igg result was 0.28 u/ml (negative).On (b)(6) 2025, the repeat result was 0.260 u/ml (negative).This sample was tested by 2 competitor methods: diasorin liaison cmv igg: 39.3 au/ml (positive).Diasorin liaison cmv igg avidity: 0.105 biomérieux vidas cmv igg: 16 au/ml (positive).Biomérieux vidas cmv igg avidity: 28 avi% the results confirm a recent primary infection with cmv.The customer suspects a missed seroconversion of the roche cmv igg assay.
Additional Manufacturer Narrative
Calibration and qc were acceptable.Four samples from the patient were received for investigation from (b)(6) 2025.The customer's results were reproducible.(b)(6) 2025 (sample 1): cmv igg: < 0.150 u/ml with a data flag (negative).Cmv igm: 0.158 coi (negative).(b)(6) 2025 (sample 2): cmv igg: 0.694 u/ml (indeterminate).Cmv igm: 34.4 coi (positive).(b)(6) 2025 (sample 3): cmv igg: 0.266 u/ml (negative).Cmv igm: 17.5 coi (positive).(b)(6) 2025 (sample 4): cmv igg: 0.265 u/ml (negative).Cmv igm: 11.7 coi (positive).The samples were investigated further.Mikrogen recomline cmv igg assay and igg avidity assay: sample 1 was negative, there was insufficient sample volume remaining for sample 2, and samples 3 and 4 were positive with low avidity.Platelia cmv igg assay: sample 1 was negative, there was insufficient sample volume remaining for sample 2, sample 3 was indeterminate, and sample 4 was positive.The investigation results revealed that the samples show a seroconversion upon primary infection with cmv, which was captured by the elecsys cmv igm assay, but was not detected with the elecsys cmv igg assay.Product labeling states: "elecsys cmv igg results should be used in conjunction with the patient¿s medical history, clinical symptoms, and other laboratory tests." the investigation did not identify a product problem.

• Brand Name: ELECSYS CMV IGG
• Common Device Name: CYTOMEGALOVIRUS IMMUNOASSAY
• 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: 23478678
• Report Number: 1823260-2025-04509
• Device Sequence Number: 10329588
• Product Code: LFZ
• UDI-Device Identifier: 07613336198469
• UDI-Public: 07613336198469
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K220911
• 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): 03/30/2026

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: 03/31/2026
• Device Model Number: CMV IGG
• Device Catalogue Number: 09118551190
• Device Lot Number: 863613
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/17/2025
• Supplement Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 03/30/2026
• 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