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

Catalog Number	07027133190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable elecsys cmv igm results for 1 patient sample on a cobas e 801 analytical unit.The initial serum sample result was 1.71 coi (reactive).The sample was recentrifuged and repeated and the result was 1.67 coi (reactive).A plasma sample collected at the same time was tested and the result was 0.332 coi (non-reactive).On either 12-apr or (b)(6) 2026, the plasma sample was repeated and the result was 0.626 coi (non-reactive).The exact date of testing was not provided.The customer deemed the non-reactive result as correct.

• Brand Name: ELECSYS CMV IGM
• 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: 24987409
• Report Number: 1823260-2026-01596
• Device Sequence Number: 10480324
• Product Code: LFZ
• UDI-Device Identifier: 04015630940189
• UDI-Public: 04015630940189
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• PMA/510(K) Number: K142133
• 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
• Report Date (Section B): 07/16/2026

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 Catalogue Number: 07027133190
• Device Lot Number: 906582
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/03/2026
• Supplement Date Received by Manufacturer: 06/26/2026
• Initial Report FDA Received Date: 04/24/2026
• Supplement Report FDA Received Date: 07/16/2026
• 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 Sex: Unknown