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

Catalog Number	07028024190
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas e 801 analytical unit 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 elecsys toxo igm results from the cobas e 801 analytical unit.The initial result was 4.26 coi (reactive).On (b)(6) 2025, the repeat result was 4.15 coi (reactive).The sample was tested in another laboratory on a competitor's chemiluminescence methodology, and the result was "negative".The toxo igm result obtained in the other laboratory was considered correct.
Additional Manufacturer Narrative
Sample material from the patient was tested as part of the investigation, and the customer's results were reproduced.Using mikrogen recomline toxo igm and biorad platelia toxo igm, the results were non-reactive.The investigation determined that the elecsys toxo igm results were falsely reactive.Per product labeling for the assay: the detection of igm antibodies against t.Gondii in a single sample is not sufficient to prove an acute toxoplasma infection since elevated igm antibody levels may persist even for years after initial infection.Further tests or a combination of test methods should be done for clarification.Elecsys toxo igm results should be used in conjunction with toxoplasma-specific igg results, the patient¿s medical history, clinical symptoms and other laboratory tests.A general reagent problem was not found.

• 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: 22642355
• Report Number: 1823260-2025-02327
• Device Sequence Number: 8632283
• Product Code: LGD
• UDI-Device Identifier: 04015630940318
• UDI-Public: 04015630940318
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 10/30/2025

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: 07028024190
• Device Lot Number: 824690
• 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: 07/09/2025
• Supplement Date Received by Manufacturer: 10/14/2025
• Initial Report FDA Received Date: 07/29/2025
• Supplement Report FDA Received Date: 10/30/2025
• 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 Sex: Female