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

Catalog Number	09118551190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the e801 analyzer is (b)(6).Samples from the patient were requested for investigation.The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received discrepant results for three patient samples tested with elecsys cmv igg on a cobas e 801 analytical unit.The first sample initially resulted in a cmv igg value of 0.150 u/ml (non-reactive) and it repeated as 0.150 u/ml (non-reactive).The sample was tested in another laboratory using a cmia method, resulting in a cmv igg value of 52.5 aiu/ml (positive) on (b)(6) 2025.The second sample initially resulted in a cmv igg value of < 0.150 u/ml (non-reactive).The sample was tested in another laboratory using a cmia method, resulting in a cmv igg value of 9.10 aiu/ml (positive).The third sample initially resulted in a cmv igg value of < 0.150 u/ml (non-reactive).The sample was tested in another laboratory using a cmia method, resulting in a cmv igg value of 3.82 aiu/ml (positive).The positive sample values were deemed correct.
Additional Manufacturer Narrative
There was not sufficient patient material left for investigation.The investigation could not identify a product problem.The cause of the event could not be determined.

• 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: 22508125
• Report Number: 1823260-2025-02153
• Device Sequence Number: 9246580
• Product Code: LFZ
• UDI-Device Identifier: 07613336198469
• UDI-Public: 07613336198469
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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): 08/15/2025

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 Catalogue Number: 09118551190
• 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: 06/25/2025
• Supplement Date Received by Manufacturer: 07/30/2025
• Initial Report FDA Received Date: 07/15/2025
• Supplement Report FDA Received Date: 08/15/2025
• 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