MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS CMV IGG; ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS

Model Number	CMV IGG
Medical Device Problem Codes	False Negative Result (1225); False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
1.Summary of investigation results: igg antibodies are a mixture of heterogeneous analytes targeted at numerous epitopes of the respective antigen and the igg distribution can vary considerably from patient to patient.Different methods use different antigens, assay principles, buffers, and solid phases for the detection of antibodies.Therefore, detection patterns of individual methods can be different in individual patient samples in dependence of the applied antigens and test formats as well as the targeted epitopes of antibodies.2.Summary of follow-up/corrective actions taken: no follow up actions taken.3.Device returned to manufacturer? no.4.Device labeled "for single use?" no.5.Device reprocessed and reused? no.
Event or Problem Description
1.Describe the event: the initial reporter complained of discrepant results for two patients tested with elecsys cmv igg on a cobas e 801 module.2.Patient age range: asku 3.Patient weight range: asku 4.Patient sex breakdown: asku 5.Patient race breakdown: asku.6.Patient ethnicity breakdown: asku.

• Brand Name: ELECSYS CMV IGG
• Common Device Name: ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS
• 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: 23066012
• Report Number: 1823260-2025-02935
• Device Sequence Number: 9671223
• Product Code: LFZ
• UDI-Device Identifier: 04015630940172
• UDI-Public: 04015630940172
• Combination Product (Y/N): N
• PMA/510(K) Number: K131605
• Exemption Number: VMSR
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/16/2025

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?: No
• Device Model Number: CMV IGG
• Device Catalogue Number: 07027117190
• Device Lot Number: ASKU
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/16/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown