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

Catalog Number	07027770190
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation about questionable high results for 3 samples from 2 patients tested with elecsys rubella igg assay on a cobas pro ssu analyzer.Patient 1: sample 1 was tested on (b)(6) 2025: elecsys rubella igg result: about 12 iu/ml and interpreted as reactive.The exact value was not provided.Chemiluminescent microparticle immunoassay (cmia from abbott) result: 3.5 and interpreted as negative.The unit of measurement was not provided.Patient 2 was tested on (b)(6) 2025: elecsys rubella igg result: 17.1 iu/ml and interpreted as reactive.Cmia rubella igg result: 2.1 u/ml and interpreted as non-reactive.Elfa rubella igg result: 2.0 u/ml and interpreted as non-reactive.Elecsys rubella igm result: non-reactive.The sample was repeated on (b)(6) 2025, and the elecsys rubella igg result was 19.3 iu/ml and interpreted as reactive.Patient 1: sample 2 was tested on (b)(6) 2025: elecsys rubella igg result: 11.2 iu/ml and interpreted as reactive.Cmia igg result: 3.3 u/ml and interpreted as negative.
Additional Manufacturer Narrative
The cobas pro ssu analyzer serial number was (b)(6).One sample was received for investigation on 06-nov-2025.The investigation is ongoing.
Additional Manufacturer Narrative
No sample for patient 2 was provided for investigation, as it was no longer available.The sample for patient 1 was received for investigation on 06-nov-2025, and the investigation determined that the reactive result in elecsys rubella igg obtained at the customer's site was correct.The product labeling states: "for diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings." the investigation did not identify a product problem.The elecsys rubella igg assay performs within specifications.

• 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: 23607426
• Report Number: 1823260-2025-04755
• Device Sequence Number: 13122842
• Product Code: LFX
• UDI-Device Identifier: 04015630940240
• UDI-Public: 04015630940240
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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
• Report Date (Section B): 04/08/2026

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 Expiration Date: 03/31/2026
• Device Catalogue Number: 07027770190
• Device Lot Number: 86531401
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/28/2025
• Supplement Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 11/20/2025
• Supplement Report FDA Received Date: 04/08/2026
• 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