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	04/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas e 801 analytical unit serial number was (b)(6).The qc was within the target range.The customer was using the reagent past its stability date.The investigation is ongoing.
Event or Problem Description
We received an allegation about discrepant results for 2 patients' samples tested with elecsys toxo igm assay on a cobas e 801 analytical unit.Patient 1 (sample 1): the initial result was 1.96 coi (accompanied by a data flag and interpreted as reactive).Patient 2 (sample 2) was tested on (b)(6) 2026: the initial result was 1.53 coi (accompanied by a data flag and interpreted as reactive).The initial results did not match the patients' history.No questionable results were reported outside the laboratory.Sample 1 and sample 2 were then repeated at a different laboratory using vidas equipment and a different assay methodology, and the repeat results were both non-reactive.The customer was leaning towards believing that the repeat results were deemed to be correct.Sample 2 was also retested at a different laboratory using roche equipment, and the repeat result was non-reactive.A clarification was requested but has not been received yet.
Additional Manufacturer Narrative
The customer used the elecsys toxo igm reagent with an expired onboard stability.No further issues were reported after the customer changed the reagent kit.A product problem was not found.The product labeling states: "stability of the cobas e pack: - unopened at 2-8 °c: up to the stated expiration date - on the analyzers: 16 weeks" the product labeling also states: "quality control for quality control, use precicontrol toxo igm.Controls for the various concentration ranges should be run individually at least once every 24 hours when the test is in use, once per cobas e pack, and following each calibration." the investigation did not identify a product problem.The cause of the event could not be determined but was consistent with using the reagent with an expired onboard stability.

• 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: 25058360
• Report Number: 1823260-2026-01713
• Device Sequence Number: 21157148
• Product Code: LGD
• UDI-Device Identifier: 04015630940318
• UDI-Public: 04015630940318
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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): 07/10/2026

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 Expiration Date: 05/31/2026
• Device Catalogue Number: 07028024190
• Device Lot Number: 87677002
• 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: 04/07/2026
• Supplement Date Received by Manufacturer: 05/04/2026; 06/15/2026
• Initial Report FDA Received Date: 05/01/2026
• Supplement Report FDA Received Date: 05/28/2026; 07/10/2026
• 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 Sex: Unknown