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	08/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient sample material was not available for investigation.For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings.The investigation could not identify a product problem.The cause of the event could not be determined.
Event or Problem Description
The initial reporter stated they received false positive elecsys toxo igg results for samples from two patients tested on a cobas e 801 module.On (b)(6) 2025, a first sample from the first patient resulted in a toxo igg value of 44.20 iu/ml (reactive).On (b)(6) 2025, a second sample from the first patient resulted in a toxo igg value of 43.40 iu/ml (reactive).On (b)(6) 2026, a third sample collected from the first patient postpartum resulted in a toxo igg value of 32.50 iu/ml (reactive).On (b)(6) 2026, a first sample collected from the second patient (daughter of first patient), resulting in a toxo igg value of 43.60 iu/ml (reactive).Since the third sample from the first patient resulted in a toxo igg value close to the assay cutoff (30 iu/ml), the (b)(6) 2026 samples from both patients were sent to an external laboratory for secondary testing.The first patient's sample from (b)(6) 2026 was tested using an unknown toxo igg clia method, resulting in a toxo igg value of < 7 ui/ml (non-reactive).An immunoblot performed with this sample had an indeterminate toxo igg result.The second patient's sample from (b)(6) 2026 was tested using an unknown toxo igg clia method, resulting in a toxo igg value of < 7 ui/ml (non-reactive).This sample was tested using an unknown toxo igg elfa method, resulting in a value of < 4 ui/ml (non-reactive).An immunoblot performed with this sample had a negative toxo igg result.
Additional Manufacturer Narrative
The serial number of the e 801 analyzer is (b)(6).The investigation is ongoing.

• 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: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 24605997
• Report Number: 1823260-2026-00923
• Device Sequence Number: 21425766
• Product Code: LGD
• UDI-Device Identifier: 04015630940301
• UDI-Public: 04015630940301
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 04/29/2026

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 Catalogue Number: 07028008190
• Device Lot Number: 86676901
• 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: 02/23/2026
• Supplement Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 03/16/2026
• Supplement Report FDA Received Date: 04/29/2026
• 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