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

Catalog Number	09118551190
Medical Device Problem Codes	False Positive Result (1227); High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The e801 analyzer serial number was (b)(6).
Event or Problem Description
The initial reporter questioned a positive result for 1 patient sample tested for elecsys cmv igg (cmv igg) on a cobas e 801 analytical unit.The initial result was 21 u/ml (positive).According to the customer¿s internal protocol, the sample was sent to an external laboratory using an e801 analyzer and the result was 5 u/ml (negative).
Additional Manufacturer Narrative
The sample that was sent to the external laboratory using an e801 analyzer was repeated, and the cmv igg result was again 5 u/ml.The external laboratory interprets this result as negative.Product labeling states that cmv igg results = 1.0 coi are interpreted as positive.Therefore, the results of 21 u/ml (from the initial report) and 5 u/ml are not discrepant; both results are positive.
Additional Manufacturer Narrative
Product labeling states that cmv igg results = 1.0 coi are interpreted as positive.All provided results were positive.The provided results were not discrepant.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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 21547964
• Report Number: 1823260-2025-00667
• Device Sequence Number: 12805615
• Product Code: LFZ
• UDI-Device Identifier: 07613336198469
• UDI-Public: 07613336198469
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,Followup
• Report Date (Section B): 05/15/2025

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: 07/31/2025
• Device Catalogue Number: 09118551190
• Device Lot Number: 80587601
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/14/2025
• Supplement Date Received by Manufacturer: 04/11/2025; 05/05/2025
• Initial Report FDA Received Date: 03/07/2025
• Supplement Report FDA Received Date: 05/01/2025; 05/15/2025
• 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