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

Catalog Number	07028024190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The e801 analyzer serial number (module 3) was (b)(6).The e801 analyzer serial number (module 2) was not provided.On 13-mar-2025, both modules were decontaminated.On (b)(6) 2025, a sample comparison was performed using 10 patient samples (5 positive and 5 negative), and the expected results were received.The patient sample in question was repeated on both modules, and the result was positive on one module and negative on the other module.The specific results were requested but have not been provided.The customer has only observed this with this one patient sample.The customer is repeating all samples with positive toxo igm results on the same analyzer and another analyzer.The gear pump pressure was adjusted on both analyzers, and the probe washes were adjusted.Calibration was last performed with reagent lot 799708 on 17-jan-2025; the results were lower but within the expected ranges.Calibration was last performed with reagent lot 824690 on 11-mar-2025; the results were lower but within the expected ranges.Qc was acceptable.Internal qc data was reviewed, and there was no difference between reagent lots 799708 and 824690.Internal control samples recovered similarly.The investigation is ongoing.
Event or Problem Description
The initial reporter questioned positive results for 1 patient sample tested for elecsys toxo igm (toxo igm) between 2 cobas e 801 analytical units (module 3 and module 2) while using a particular reagent lot.The initial result from module 3 using reagent lot 824690 was 1.15 coi (positive).The repeat result from module 2 using reagent lot 799708 (expiration 31-may-2025) was 0.472 coi (negative).On (b)(6) 2025 the sample was repeated on module 2 using reagent lot 799708 and the result was 0.471 coi (negative).The sample was repeated on module 3 using reagent lot 824690, and the result was 1.13 coi (positive).On (b)(6) 2025 the sample was repeated on module 3 using reagent lot number 799708, and the result was 0.474 coi (negative).The sample was repeated on module 2 using reagent lot number 799708, and the result was 0.456 coi (negative).The sample was repeated on module 3 using reagent lot number 799708, and the result was 0.486 coi (negative).No questionable results were reported outside of the laboratory.
Additional Manufacturer Narrative
The customer repeated other patient samples with positive toxo igm results on module 3 and module 2, and the results were reproducible.The patient sample in question was not tested further by the customer as the toxoplasma igg result was negative.A new sample from this patient has not been obtained.
Additional Manufacturer Narrative
The investigation did not identify a product problem.The cause of the event could not be determined.
Additional Manufacturer Narrative
The customer requests an investigation of the patient sample.The most recent test result was obtained during comparison testing on march 13, 2025, and the toxo igm result was 1.24 coi (positive).On (b)(6) 2025, the sample was tested using a different reagent kit but the same lot number (824690) on module 2 with a result of 1.17 coi (positive) and on module 3 with a result of 1.18 coi (positive).
Additional Manufacturer Narrative
Sample material was submitted for investigation.The following results were received: elecsys toxo igm: positive with 3 reagent lots.Elecsys toxo igg: < 0.13 iu/ml (negative).Recomline toxo igm: negative.Platelia toxo igm: 0.17 (negative).Igm-type label interferent: not detected.The customer's positive toxo igm results were reproduced.Based on the other results produced during the investigation, false positive results due to an unknown interference cannot be excluded.Product labeling states: "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." 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 21739607
• Report Number: 1823260-2025-00960
• Device Sequence Number: 17139079
• Product Code: LGD
• UDI-Device Identifier: 04015630940318
• UDI-Public: 04015630940318
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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,Followup,Followup
• Report Date (Section B): 11/03/2025

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: 03/11/2025
• Supplement Date Received by Manufacturer: 04/02/2025; 04/29/2025; 05/13/2025; 10/17/2025
• Initial Report FDA Received Date: 04/01/2025
• Supplement Report FDA Received Date: 04/25/2025; 05/06/2025; 06/02/2025; 11/03/2025
• 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