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	03/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter questioned a negative result for 1 patient sample tested for elecsys cmv igg (cmv igg) on a cobas e 801 analytical unit.The result from the e801 analyzer was < 15 u/ml (negative).The result from a competitor method was 38 (positive).The unit of measure was not provided.
Additional Manufacturer Narrative
The e801 analyzer serial number was (b)(6).The competitor method was vidas.
Additional Manufacturer Narrative
The customer complained of a questionable negative cmv igg result for an additional patient sample (patient 2): on (b)(6) 2025, the result from the e801 analyzer was <0.15 u/ml (negative).The result from the vidas method was 8 au/ml (positive).Sections b6 and b7 were updated.For patient 1, the initial report stated: "the result from the e801 analyzer was <15 u/ml (negative)." this should say: "the result from the e801 analyzer was < 0.15 u/ml (negative)." sample material was requested for investigation.
Additional Manufacturer Narrative
Calibration and qc were acceptable.Sample material was requested for investigation, but was not provided.As no sample material was available, the cause of the event could not be determined.The investigation did not identify a product problem.

• 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 21866320
• Report Number: 1823260-2025-01185
• Device Sequence Number: 11941856
• 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,Followup,Followup
• Report Date (Section B): 07/10/2025

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: 09/30/2025
• Device Catalogue Number: 09118551190
• Device Lot Number: 82318601
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/28/2025
• Supplement Date Received by Manufacturer: 04/22/2025; 07/07/2025
• Initial Report FDA Received Date: 04/18/2025
• Supplement Report FDA Received Date: 05/07/2025; 07/10/2025
• 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