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

Model Number	CMV IGG
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable elecsys cmv igm and elecsys cmv igg results from one patient from the cobas e 801 module.This medwatch is for the elecsys cmv igg assay.Refer to the medwatch with a1 patient identifier (b)(6) for the elecsys cmv igm assay.Sample 1 (b)(6) 2025) at 10 weeks of pregnancy: the elecsys cmv igm result was 0.38 coi with a data flag (negative).The elecsys cmv igg result was 0.150 u/ml with a data flag (negative).On (b)(6) 2025, the diasorin liaison cmv igm result was 23.1 ua/ml (positive).The diasorin liaison cmv igg result was 48 ua/ml (positive).The diasorin liaison cmv igg avidity result was 0.0493.The vidas biomérieux cmv igg result was <6 ua/ml (greyzone/equivocal).On (b)(6) 2025, the repeat elecsys cmv igm result using reagent lot 848029 was 0.40 coi (negative).Elecsys cmv igg result using reagent lot 836250 was 0.150 u/ml with a data flag (negative).Sample 2 (b)(6) 2025) 19 weeks of pregnancy: the elecsys cmv igm result was 2.72 coi.The repeat result was 2.67 coi (positive).The elecsys cmv igg result was 10.8 u/ml.The repeat result was 10.6 u/ml (positive).On (b)(6) 2025, the diasorin liaison cmv igm result was 25.4 ua/ml (positive).The diasorin liaison cmv igg result was 155 ua/ml (positive).The diasorin liaison cmv igg avidity result was 0.0797.The vidas biomérieux cmv igg result was 43 ua/ml (positive).The vidas biomérieux cmv igg avidity result was 59 %.Sample 3 (b)(6) 2025) 27 weeks of pregnancy: on (b)(6) 2025, the diasorin liaison cmv igm result was 30.1 ua/ml (positive).The diasorin liaison cmv igg result was 180 ua/ml (positive).The diasorin liaison cmv igg avidity result was 0.156.The vidas biomérieux cmv igg result was 108 ua/ml (positive).The vidas biomérieux cmv igg avidity result was 74 %.
Additional Manufacturer Narrative
The cobas e 801 module serial number was (b)(6).As sufficient sample material remained, further investigation was not possible.The investigation was not able to determine a specific root cause.No product problem was found.

• 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: 23696221
• Report Number: 1823260-2025-04910
• Device Sequence Number: 21426462
• Product Code: LFZ
• UDI-Device Identifier: 07613336198469
• UDI-Public: 07613336198469
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 12/02/2025

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: 09/25/2025
• Device Model Number: CMV IGG
• Device Catalogue Number: 09118551190
• Device Lot Number: 823186
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/07/2025
• Initial Report FDA Received Date: 12/02/2025
• 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 Age: 32 YR
• Patient Sex: Female