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

Model Number	CMV IGG
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
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 pure e 402 analytical unit and a cobas e 801 module.2.Patient age range: 2 asku.3.Patient weight range: 2 asku.4.Patient sex breakdown: 2 asku.5.Patient race breakdown: 2 asku.6.Patient ethnicity breakdown: 2 asku.
Additional Manufacturer Narrative
The expiration date for reagent lot: 657967 is 30-sep-2023.The expiration date for reagent lot: 52258301 is 30-apr-2022.For one of the events: 1.Summary of investigation results: the investigation determined that dilution studies performed by the customer indicated non-linear dilution behavior associated with a high dose hook effect.This may result in a strong reactivity to one of the submodules of the elecsys cmv igg assay.2.Summary of follow-up/corrective actions taken: no follow up actions taken.For one of the events: 1.Summary of investigation results: investigations determined the issue is related to a sample specific discrepancy.The sample shows non-linear dilution behavior which interferes with robust determination of avidity.Still, cmv igg reactivity could be confirmed and a transient phase between early and late phase of infection seems likely.The elecsys cmv igg reagent performs within specification.2.Summary of follow-up/corrective actions taken: a sample from the patient was provided for investigation.3.Device returned to manufacturer? no.4.Device labeled ""for single use?" no.5.Device reprocessed and reused? no.

• 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: 23066069
• Report Number: 1823260-2025-02932
• Device Sequence Number: 18604418
• Product Code: LFZ
• UDI-Device Identifier: 07613336198469
• UDI-Public: 07613336198469
• Combination Product (Y/N): N
• PMA/510(K) Number: K220911
• Exemption Number: VMSR
• Number of Events Summarized: 2
• 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: 09118551190, 07027117190
• Device Lot Number: 657967, 52258301
• 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