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

Catalog Number	09118551190
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The e801 analyzer serial number was (b)(6).The competitor method was vidas.
Event or Problem Description
The initial reporter questioned a negative result for 1 patient sample tested for elecsys cmv igg (cmv igg) on a cobas e 801 analytical unit.The initial result from the e801 analyzer was 0.496 u/ml (negative).The sample was repeated twice on the analyzer with results of 0.480 u/ml (negative) and 0.478 u/ml (negative).The sample was repeated using a competitor method, and the result was 15 u/ml (positive).
Additional Manufacturer Narrative
Calibration was last performed on 15-apr-2025 with no issues.Qc data from 16-may-2025 was acceptable.Based on the results provided, an acute primary infection is indicated for this patient.The investigation determined that the sample originates from a patient currently undergoing seroconversion, during which iggs against various target antigens are being generated.Due to the polyclonal human immune response after contact with a pathogen, the resulting igg antibodies are diverse, since they are targeted to different antigens of the pathogen and are of different subclasses and of different maturation states.Different methods use different antigens, assay principles, buffers, and solid phases for the detection of antibodies.Therefore, detection patterns of individual methods can be different in individual patient samples.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: 22167673
• Report Number: 1823260-2025-01770
• Device Sequence Number: 20780723
• Product Code: LFZ
• UDI-Device Identifier: 07613336198469
• UDI-Public: 07613336198469
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 06/25/2025

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: 09/30/2025
• Device Catalogue Number: 09118551190
• Device Lot Number: 82318601
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/19/2025
• Supplement Date Received by Manufacturer: 06/17/2025
• Initial Report FDA Received Date: 06/09/2025
• Supplement Report FDA Received Date: 06/25/2025
• 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