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

Catalog Number	07028024190
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation about questionable low results for 2 samples from 1 patient tested with elecsys toxo igm assay on a cobas e 801 analytical unit.Sample 1: elecsys toxo igm eclia result: 0.77 coi and interpreted as non-reactive.Vidas toxo igm (elfa) result: 0.68.The unit of measurement was not provided.Interpreted as indeterminate.Sample 2 was tested on (b)(6) 2025: elecsys toxo igm result: 0.49 coi and interpreted as non-reactive.Vidas toxoplasmosis igm (elfa) result: 0.56.The unit of measurement was not provided.Interpreted as indeterminate.
Additional Manufacturer Narrative
The cobas e 801 analytical unit serial number was (b)(6).The calibration was last performed on (b)(6) 2025, and it was within the expected ranges.The qc was within the specified ranges on the days of the samples' collection.The sample material was not available for investigation.The investigation is ongoing.
Additional Manufacturer Narrative
The provided sample results did not indicate an early infection with toxoplasma.The low reactive/borderline toxo igm results (elfa) might be indicative of persisting igm.The investigation did not identify a product problem.The elecsys toxo igm assay performs within specification.
Additional Manufacturer Narrative
Medwatch field b6 was updated.The customer alleged additional test results from additional samples (samples 3 and 4) for the patient: on (b)(6) 2025: elecsys toxo igm eclia: 0.42 coi.Interpreted as non-reactive.Vidas toxo igm elfa: 0.56.The unit of measurement was not provided.Interpreted as indeterminate.On (b)(6) 2025: elecsys toxo igm eclia: 0.33 coi.Interpreted as non-reactive.Vidas toxo igm elfa: 0.42.The unit of measurement was not provided.Interpreted as non-reactive.

• Brand Name: ELECSYS TOXO IGM
• 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: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 23638039
• Report Number: 1823260-2025-04810
• Device Sequence Number: 21133031
• Product Code: LGD
• UDI-Device Identifier: 04015630940318
• UDI-Public: 04015630940318
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K162678
• 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,Followup
• Report Date (Section B): 02/24/2026

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: 01/31/2026
• Device Catalogue Number: 07028024190
• Device Lot Number: 85586801
• 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: 11/03/2025
• Supplement Date Received by Manufacturer: 01/02/2026; 01/29/2026
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 01/26/2026; 02/24/2026
• 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: Female