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

Catalog Number	07027770190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the e 801 analyzer is (b)(6).The patient's sample was requested for investigation.The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with elecsys rubella igg on a cobas e 801 analytical unit.The sample resulted in a rubella igg value of 5.54 iu/ml (negative).The result contradicted the patient's positive history, so the sample was repeated on a liaison system, resulting in a positive outcome consistent with the patient's history.Rubella igg values were consistently low when repeated with the roche assay.No specific repeat values were provided other than a value of 5.85 iu/ml (negative).
Additional Manufacturer Narrative
Calibration and controls were acceptable.The patient's sample was no longer available for investigation.The investigation could not identify a product problem.The cause of the event could not be determined.The elecsys rubella igg assay performs within specification.

• 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: 23535510
• Report Number: 1823260-2025-04607
• Device Sequence Number: 15994361
• Product Code: LFX
• UDI-Device Identifier: 04015630940240
• UDI-Public: 04015630940240
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 01/27/2026

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): Follow-Up
• Initial Date Received by Manufacturer: 10/24/2025
• Supplement Date Received by Manufacturer: 01/12/2026
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 01/27/2026
• 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