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

Catalog Number	04618858190
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas e411 disk serial number was (b)(6).Sample material from the patient was requested for further investigation.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable false-positive elecsys toxo igm results from the cobas e411 disk analyzer.Example 1 had an initial result of 1.2 (reactive).The patient was checked in another lab using a different method, and the toxo igm result was negative.Example 2 had an initial result that was reactive.The patient was checked in another lab using the abbott method, and the toxo igm result was negative.No specific data was provided.Example 3 initial result was 1.2 coi (reactive).After high-speed centrifugation, the result was 1.1 coi (reactive).The result from another laboratory using a non-roche method was negative.On (b)(6) 2025, the sample was repeated on a cobas pure analyzer, and the result was 0.94 coi (equivocal).
Additional Manufacturer Narrative
Medwatch field b7 other relevant history was updated.Specific data was provided for example 2: the initial toxo igm results were repeatedly reactive (1 - 1.8 coi).The elecsys toxo igm result from a cobas e 402 analyzer was 1.5 coi (reactive).Sample material for example 3 was received for investigation.The customer¿s reactive result with elecsys toxo igm was reproducible and confirmed with a different method (eia).Considering all data, patient 3 likely had a remote infection with toxoplasma gondii, with persisting, detectable levels of toxoplasma igm antibodies.The investigation did not identify a product problem.

• 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: 22344783
• Report Number: 1823260-2025-01970
• Device Sequence Number: 15585149
• Product Code: LGD
• UDI-Device Identifier: 04015630921485
• UDI-Public: 04015630921485
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• 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
• Report Date (Section B): 08/21/2025

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: 08/31/2025
• Device Catalogue Number: 04618858190
• Device Lot Number: 82468601
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/07/2025
• Supplement Date Received by Manufacturer: 08/06/2025
• Initial Report FDA Received Date: 06/27/2025
• Supplement Report FDA Received Date: 08/21/2025
• 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: 32 YR
• Patient Sex: Female