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

Catalog Number	07027770190
Medical Device Problem Codes	False Positive Result (1227); High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable elecsys rubella igg results for 1 patient on a cobas e 801 analytical unit.On (b)(6) 2025, the patient's result using the diasorin method was negative.In (b)(6) 2025 (unspecified date), the patient's result in a different laboratory (unspecified method) was "doubtful / borderline positive".On (b)(6) 2025, the patient's elecsys rubella igg result was 35.6 ui/ml (positive).On (b)(6) 2026, the patient's result using the diasorin method was negative.The elecsys rubella igg result for this sample was 27 ui/ml (positive).The sample was tested in another laboratory and was found to be non-reactive for rubella igg antibodies (no method provided).
Additional Manufacturer Narrative
E1 initial reporter establishment name: (b)(6).The analyzer's serial number is (b)(6).The sample was received for investigation.The investigation is ongoing.
Additional Manufacturer Narrative
The returned sample was investigated.The customer's reactive elecsys rubella igg result was reproducible during the investigation.Additional testing confirmed the elecsys result, and the avidity measurements showed grey zone avidity.Based on the available data, the elecsys result is considered a correct positive (reactive).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.

• 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: 24247897
• Report Number: 1823260-2026-00364
• Device Sequence Number: 9593492
• Product Code: LFX
• UDI-Device Identifier: 04015630940240
• UDI-Public: 04015630940240
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 04/22/2026

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: 07/31/2026
• Device Catalogue Number: 07027770190
• Device Lot Number: 89304001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/09/2026
• Supplement Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 02/03/2026
• Supplement Report FDA Received Date: 04/22/2026
• 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: Female