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

Catalog Number	07027770190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable elecsys rubella igg results for three patient samples tested on a cobas e 402 analytical unit compared to a reference lab.Sample 1: the initial result was 40.5 iu/ml (positive).The repeat result at a reference lab was negative.Sample 2: the initial result was 45 iu/ml (positive).The repeat result at a reference lab was negative.Sample 3: the initial result was 46.2 iu/ml (positive).The repeat result at a reference lab was negative.
Additional Manufacturer Narrative
The serial number of the analyzer is (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
Medwatch field d4 lot no was updated.Two additional patient samples were reported by the customer, showing discrepant reactive elecsys rubella igg results: sample 4: on (b)(6) 2026, the initial result was 45.4 iu/ml (positive).The repeat result at a reference lab was negative.Sample 4: on (b)(6) 2026, the initial result was 13.1 iu/ml (positive).The repeat result at a reference lab was negative.The test used by the reference lab was the abbott alinity rubella igg.

• Brand Name: ELECSYS RUBELLA IGG
• Common Device Name: ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA
• 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: 24686330
• Report Number: 1823260-2026-01069
• Device Sequence Number: 13188218
• Product Code: LFX
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K072617
• 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): 06/24/2026

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: 07027770190
• Device Lot Number: 893040
• 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: 03/02/2026
• Supplement Date Received by Manufacturer: 04/16/2026; 06/02/2026
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 05/11/2026; 06/24/2026
• 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 Age: 37 YR
• Patient Sex: Unknown