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

Catalog Number	07028008190
Medical Device Problem Codes	False Positive Result (1227); High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received questionable results for three samples collected from the same patient tested with elecsys toxo igg and elecsys toxo igm on a cobas e 801 analytical unit.This medwatch will apply to the toxo igg assay.Please refer to the medwatch with a1.Patient identifier (b)(6) for information related to the toxo igm assay.On (b)(6) 2026, a first sample collected from the patient resulted in a toxo igg value of 9.3 iu/ml (reactive) and a toxo igm value of 2.38 coi (reactive).On (b)(6) 2026, a second sample collected from the patient resulted in a toxo igg value of 8.4 iu/ml (reactive) and a toxo igm value of 2.36 coi (reactive).On (b)(6) 2026, a third sample collected from the patient resulted in a toxo igg value of 9.0 iu/ml (reactive) and a toxo igm value of 2.49 coi (reactive).This sample was tested for toxo igg avidity and the result was 66.5 % (avidity low).In the same time period on unknown dates, the patient had follow up testing at two additional sites.The first site used a diasorin instrument and both toxo igg and toxo igm were negative.The second site used an autobio instrument and resulted in a negative toxo igg value, a negative toxo igg affinity value, and a questionable toxo igm value.No specific results were provided.
Additional Manufacturer Narrative
The serial number of the e 801 analyzer is (b)(6).Calibration and controls were acceptable.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: 24840059
• Report Number: 1823260-2026-01391
• Device Sequence Number: 17648959
• Product Code: LGD
• UDI-Device Identifier: 04015630940301
• UDI-Public: 04015630940301
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 06/17/2026

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: 03/26/2026
• Supplement Date Received by Manufacturer: 05/29/2026
• Initial Report FDA Received Date: 04/10/2026
• Supplement Report FDA Received Date: 06/17/2026
• 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 Age: 35 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic