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

Model Number	CMV IGG
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The e801 analyzer serial number was (b)(6).Calibration and qc were acceptable.The investigation is ongoing.
Event or Problem Description
The initial reporter complained of discrepant results for 2 samples from 1 patient tested for elecsys cmv igg (cmv igg) on a cobas e 801 analytical unit when compared to competitor methods.The patient was first tested on (b)(6) 2026 with the following results: the result from the e801 analyzer was 1.27 iu/ml (positive).The result from the abbott method was 68.7 ua/ml (positive).The result from the diasorin method was 88.6 u/ml (positive).The cmv igg avidity result from the vidas method was 43% (moderate).The diasorin parvovirus b19 result was 54.90 u/ml (positive).A new sample was obtained on (b)(6) 2026 with the following results: the result from the e801 analyzer was 0.967 iu/ml (indeterminate).The result from the abbott method was 77.8 ua/ml (positive).The cmv igg avidity result from the vidas method was 45% (moderate).A new sample was obtained on (b)(6) 2026 with the following results: the result from the e801 analyzer was 0.590 iu/ml (indeterminate).The result from the abbott method was 79 ua/ml (positive).The result from the diasorin method was 90.8 u/ml (positive).The cmv igg avidity result from the vidas method was 46% (moderate).

• 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: 24818675
• Report Number: 1823260-2026-01346
• Device Sequence Number: 9686580
• Product Code: LFZ
• UDI-Device Identifier: 07613336198469
• UDI-Public: 07613336198469
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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
• Report Date (Section B): 04/08/2026

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 Model Number: CMV IGG
• Device Catalogue Number: 09118551190
• Device Lot Number: 906916
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 04/08/2026
• 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 Age: 33 YR
• Patient Sex: Female