MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS TOXO IGG; ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII

Catalog Number	07028008190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the customer's cobas e 801 module (b)(6).The patient samples were requested for investigation.The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable elecsys toxo igg results from two samples from the same patient tested on the cobas e 801 module.Sample 1: the patient sample was sent to another laboratory for avidity testing.The laboratory uses the line immune assay (lia) laboratory method.On (b)(6) 2024: the initial result from the module was 97.4 iu/ml.On (b)(6) 2024: the first repeat result from the lia method was negative.On (b)(6) 2024: the second repeat result from the lia method was negative.Sample 2: the patient sample was sent to another laboratory for avidity testing.The laboratory uses an abbott analyzer with chemiluminescence microplate immunoassay (cmia) as the laboratory method.On (b)(6) 2024: the initial result from the module was 100.0 iu/ml.On (b)(6) 2024: the repeat result from the cmia method was 2.3 iuml (borderline).The results from (b)(6) 2024 were reported to the patient.The physician suspects an interference may have caused the event.
Additional Manufacturer Narrative
The calibration and qc results were within specifications.One (1) patient sample was received for investigation.The investigation was able to reproduce the customer's results.The result was assessed as a correct reactive based on elecsys toxo igg neutralization and anti-toxo igg lineblot assay results.The investigation noted that the patient sample was non-reactive for anti-toxo igm and had high avidity for anti-toxo igg; the results are consistent with a remote state of infection.The reagent performed within specifications.The investigation did not identify a product problem.

• Brand Name: ELECSYS TOXO IGG
• Common Device Name: ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII
• 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: 21148859
• Report Number: 1823260-2025-00123
• Device Sequence Number: 21233157
• Product Code: LGD
• UDI-Device Identifier: 04015630940301
• UDI-Public: 04015630940301
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K073501
• 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: 11/30/2025
• Device Catalogue Number: 07028008190
• Device Lot Number: 78702701
• 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: 12/23/2024
• Supplement Date Received by Manufacturer: 02/25/2025
• Initial Report FDA Received Date: 01/14/2025
• 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 Age: 30 YR
• Patient Sex: Female