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	10/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the cobas e 801 analytical unit is (b)(6).The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable elecsys rubella igg results from 24 patient samples tested on the cobas e 801 analytical unit.Please refer to the attachment (b)(6) in the medwatch for the table containing the examples of questionable results.
Additional Manufacturer Narrative
The calibration and qc results were within specifications.The investigation determined the event was consistent with a sample-specific discrepancy.The product labeling states, "limitations - interference - a test result <10 iu/ml does not completely rule out the possibility of an acute rubella infection.Specimens taken very early in the acute phase of infection may not contain any detectable amounts of anti-rubella igg or may have an antibody concentration < 10 iu/ml." 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 20695423
• Report Number: 1823260-2024-03335
• Device Sequence Number: 6556096
• 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): 03/10/2025

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: 10/31/2024
• Device Catalogue Number: 07027770190
• Device Lot Number: 76406101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/28/2024
• Supplement Date Received by Manufacturer: 02/25/2025
• Initial Report FDA Received Date: 11/15/2024
• Supplement Report FDA Received Date: 03/10/2025
• 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