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	03/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample material was not available for investigation.The investigation did not identify a product problem.The product labeling states the following for reactive results: a positive toxo igm test result in a single sample, also in combination with a negative toxo igg result, is not sufficient to prove an acute toxoplasma gondii infection: elevated igm antibody levels may persist even for years after initial infection.Further tests or a combination of test methods should be done for clarification.In very rare cases false reactive toxo igm results may occur.If toxo igm results are inconsistent with clinical evidence, additional testing is suggested to confirm the result.For diagnostic purposes, results should be used in conjunction with other data (e.G.Results of other tests such as toxo igg and toxo igg avidity), and clinical impressions, that might however be unspecific.In diagnosis of toxoplasma infection, particularly during pregnancy if therapeutic decisions depend on the diagnosis, the current local or if not available global medical guidelines provided by professional medical societies are to be followed.The product labeling states the following for borderline results: samples with a cutoff index between = 0.8 and < 1.0 are considered indeterminate.The sample should be retested.In case the result is still indeterminate, a second sample should be tested e.G.Within 2-3 weeks.
Additional Manufacturer Narrative
The cobas e411 disk serial number was (b)(6).Calibration was performed on (b)(6) 2024 and was acceptable.Qc recovery on (b)(6) 2024 and (b)(6) 2024 were acceptable.The investigation is ongoing.
Event or Problem Description
We received an allegation about questionable results for 1 patient sample tested with elecsys toxo igm assay on a cobas e411 immunoassay analyzer when compared to a non-roche (vidas) analyzer.On (b)(6) 2024 the sample was tested on vidas, resulting in a value of 0.04 and interpreted as negative.The unit of this measurement was not provided.On (b)(6) 2024 the sample was tested on e411, resulting in a value of 1.15 coi and interpreted as positive.

• 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: 19070516
• Report Number: 1823260-2024-01076
• Device Sequence Number: 4657819
• Product Code: LGD
• UDI-Device Identifier: 04015630921485
• UDI-Public: 04015630921485
• Combination Product (Y/N): Y
• 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
• Report Date (Section B): 05/03/2024

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: 07/31/2024
• Device Catalogue Number: 04618858190
• Device Lot Number: 740654
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/19/2024
• Supplement Date Received by Manufacturer: 04/12/2024
• Initial Report FDA Received Date: 04/09/2024
• Supplement Report FDA Received Date: 05/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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