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	02/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the e801 analyzer is (b)(6).Samples from the patients have been provided for investigation.The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received questionable results for two patient samples tested with elecsys toxo igm on a cobas e 801 analytical unit.The results were negative, but clinicians flagged these patients as likely positive based on previous positive reports from another laboratory.The first sample resulted in a toxo igm value of 0.29 coi (non-reactive) on the e801 analyzer.The sample was repeated using the vidas toxo igm method, resulting in a value of 0.74 index (reactive).The sample was also tested using the liaison toxo igm method, and the result was 28.4 index (reactive).The second sample resulted in a toxo igm value of 0.468 coi (non-reactive) on the e801 analyzer on (b)(6) 2025.The sample was repeated using the vidas toxo igm method, resulting in a value of 0.92 index (reactive).The sample was also tested using the liaison toxo igm method, and the result was 21.2 index (reactive).
Additional Manufacturer Narrative
Quality controls were acceptable.Investigations of the patient samples were able to reproduce the results obtained by the customer.The samples were tested with the elecsys toxo igg avidity assay and both samples had low avidity.The samples were positive when tested with the biorad platelia toxo igm method.When tested with the mikrogen toxo igm recomline blot method, the first sample was non-reactive and the second sample was reactive.The investigation data indicates that both patient have an early acute infection.A second sample should be tested within two weeks.The investigation did not identify a product issue.

• 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: 22507772
• Report Number: 1823260-2025-02151
• Device Sequence Number: 8745988
• 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
• Report Date (Section B): 09/05/2025

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 Catalogue Number: 07028024190
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/25/2025
• Supplement Date Received by Manufacturer: 08/21/2025
• Initial Report FDA Received Date: 07/15/2025
• Supplement Report FDA Received Date: 09/05/2025
• 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