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	04/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the analyzer was (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable elecsys toxo igm results for 2 patients on a cobas e 801 analytical unit.Sample 1 on (b)(6) 2025: the elecsys toxo igm results were 1.37 coi (reactive) and 1.25 coi (reactive).The elecsys toxo igg result was non-reactive.The avidity igg result was low avidity.The toxo igm result using another method was 0.06 (non-reactive).Sample 2 (two different samples from the same patient) on (b)(6) 2025: the elecsys toxo igm results were 1.44 coi (reactive) and 1.40 coi (reactive).The elecsys toxo igg result was non-reactive.On (b)(6) 2025: the elecsys toxo igm result was 1.30 coi (reactive).The elecsys toxo igg results was non-reactive.The toxo igm result using another method was 0.05 coi (non-reactive).The toxo igg result using another method was 0.2 iu/ml (non-reactive).
Additional Manufacturer Narrative
One additional sample was alleged to have generated questionable results.Sample 3: date unknown: the elecsys toxo igm result was positive.The repeat result using another methodology was negative.No numeric results were provided.Calibration signals between 13-nov-2024 and 28-apr-2025 were found within expected ranges.Additionally, qc recoveries from 08-apr-2025 and 20-may-2025 were found within specified ranges.Sample material was requested for investigation.
Additional Manufacturer Narrative
Qc and calibration were acceptable.The customer collected 20 samples between (b)(6) 2025 and sent them for investigation.19 out of the 20 samples were positive for elecsys toxo igm and negative for vidas toxo igm.Elecsys toxo igg and pcr testing resulted in negative.The remaining sample was also positive with vidas toxo igm; therefore, showing no discrepancy.The customer¿s reactive results in elecsys toxo igm were reproducible.Extensive analysis of the 20 patient samples revealed that 7 patient samples were true positive results.For 6 patient samples, the discrepancy was likely caused by the high sensitivity of elecsys toxo igm.The remaining 13 samples were false positive results that were caused by either label-interfering compounds (11 patient samples) or uncharacterized compounds (2 patient samples).Per the product labeling, "in rare cases, interference due to extremely high titers of antibodies to immunological components, streptavidin or ruthenium can occur.These effects are minimized by suitable test design." 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: 22529754
• Report Number: 1823260-2025-02181
• Device Sequence Number: 7488282
• 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,Followup
• Report Date (Section B): 12/18/2025

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
• 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: 06/25/2025
• Supplement Date Received by Manufacturer: 07/22/2025; 12/04/2025
• Initial Report FDA Received Date: 07/17/2025
• Supplement Report FDA Received Date: 08/14/2025; 12/18/2025
• 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: Unknown