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

Model Number	CMV IGG
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas e 801 analytical unit serial number is (b)(6).
Event or Problem Description
The initial reporter received a questionable positive elecsys cmv igg result from one patient sample tested on the cobas e 801 analytical unit.On (b)(6) 2026: the initial result of the initial patient sample collected on (b)(6) 2026 was 7.69 u/ml (positive).On (b)(6) 2026: the repeat result of the initial patient sample from another analyzer was <0.150 u/ml with a data flag (negative).On (b)(6) 2026, a new sample was obtained, and the result from the other analyzer was <0.150 u/ml with a data flag (negative).

• 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: 24552078
• Report Number: 1823260-2026-00832
• Device Sequence Number: 9339509
• Product Code: LFZ
• UDI-Device Identifier: 07613336198469
• UDI-Public: 07613336198469
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 06/01/2026

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: 06/30/2026
• Device Model Number: CMV IGG
• Device Catalogue Number: 09118551190
• Device Lot Number: 878438
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/16/2026
• Supplement Date Received by Manufacturer: 05/08/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 06/01/2026
• 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