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	05/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The e601 module serial number was (b)(6).The investigation is ongoing.
Event or Problem Description
We received an allegation about questionable high results for 15 patients' samples tested with elecsys toxo igm assay on a cobas 6000 e601 module when compared to 2 different competitors (liaison and vidas) at a different laboratory.Below are the discrepant results for 3 patients' samples.Sample 1: initial result: 1.34.Repeat result: negative (tested on liaison).Sample 2 was tested on (b)(6) 2025: initial result: 1.61.Repeat result: 0.08 and interpreted as negative (tested on vidas).Sample 3 was tested on (b)(6) 2025: initial result: 1.85.Repeat result: 0.35 and interpreted as negative (tested on vidas).The units of measurement were not provided.The customer alleged that the repeat results did not confirm the initial positive results.
Additional Manufacturer Narrative
Correction: section b3 was updated.The customer alleged discrepant results for an additional patient sample tested with elecsys toxo igm assay: sample 16 tested on (b)(6) 2025: initial result: 1.5.Repeat result: 0.03 and interpreted as negative (tested on vidas).The units of measurement were not provided.Sample 16 was requested for investigation.The investigation is ongoing.
Additional Manufacturer Narrative
Two samples (sample 1 and sample 3) were received for investigation on 05-sep-2025: sample 1: further investigation of toxoplasma igm: elecsys toxo igm result: 1.5 coi (reactive).Vidas toxo igm result: 0.03 index (negative).Sample 3: further investigation of toxoplasma igm: elecsys toxo igm result: 0.82 coi (borderline) vidas toxo igm result: 0.17 index (negative).The investigation results were as follows: elecsys toxo igm: sample 1: 1.32 coi (reactive).Sample 3: 0.93 coi (borderline).Elecsys toxo igg: sample 1: <0.180 iu/ml (non-reactive).Sample 3: 359 iu/ml (reactive).Elecsys toxo igg avidity: sample 1: not applicable.Sample 3: 74.6 avi% (indeterminate).Platelia toxo igm: sample 1: 0.17 coi (non-reactive).Sample 3: 0.22 coi (non-reactive).Mikrogen recomline toxo igm: sample 1 and sample 3: non-reactive.Label interference: sample 1 and sample 3: observed reactivity not based on label interference.Neutralization: sample 3: neutralizable.The product labeling states: "for diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings." the cause of the event was as follows: sample 1: to determine whether the elecsys toxo igm reactivity indicated an early acute infection or was caused by unspecific/cross-reactive igms, further testing with a follow-up sample should be performed.Sample 3: possibly was derived from a patient with a late acute infection that had persisting igm antibodies.The investigation did not identify a product problem.The assay performs within specifications.

• 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: 22344596
• Report Number: 1823260-2025-01964
• Device Sequence Number: 18270935
• Product Code: LGD
• UDI-Device Identifier: 04015630921485
• UDI-Public: 04015630921485
• 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,Followup
• Report Date (Section B): 03/13/2026

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: 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): Follow-Up
• Initial Date Received by Manufacturer: 06/03/2025
• Supplement Date Received by Manufacturer: 06/30/2025; 02/20/2026
• Initial Report FDA Received Date: 06/27/2025
• Supplement Report FDA Received Date: 07/25/2025; 03/13/2026
• 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