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	06/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas e 801 analytical unit serial number is (b)(6).The first competitor analyzer = abbott.The second competitor analyzer = "cnr".The investigation included a review of the calibration, qc data, and alarm trace: the calibration results were within the specified ranges.The qc results were within the specified ranges.The patient sample was requested for investigation.
Event or Problem Description
The initial reporter received a questionable positive elecsys rubella igg assay result from one patient sample tested on the cobas e 801 analytical unit.On (b)(6) 2025, the initial result from the analyzer was 19.40 ui/ml (positive).The patient sample was sent out to two other laboratories: on (b)(6) 2025, the repeat result from the first competitor analyzer was 2.6 ui/ml (negative).On (b)(6) 2025, the repeat result from the second competitor analyzer was 5.64 ui/ml (negative).
Additional Manufacturer Narrative
In the initial medwatch, the fourth line of h11 additional narrative should have been: "the investigation included a review of the calibration, qc data:" instead of: "the investigation included a review of the calibration, qc data, and alarm trace:" the patient sample was not submitted for investigation.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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: 22776019
• Report Number: 1823260-2025-02438
• Device Sequence Number: 13096840
• Product Code: LFX
• UDI-Device Identifier: 04015630940240
• UDI-Public: 04015630940240
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 11/03/2025

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: 07/31/2025
• Device Catalogue Number: 07027770190
• Device Lot Number: 815316
• 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: 07/17/2025
• Supplement Date Received by Manufacturer: 10/14/2025
• Initial Report FDA Received Date: 08/11/2025
• Supplement Report FDA Received Date: 11/03/2025
• 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