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

Catalog Number	07028024190
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The e801 module serial number is (b)(6).The serial number for the cobas pro module was not provided.Competitor method 1 is vidas biomérieux.Competitor method 2 is diasorin liaison xl.Competitor method 3 is abbott alinity.The sample was requested for investigation.
Event or Problem Description
The initial reporter questioned negative results for 1 patient sample tested for elecsys toxo igm (toxo igm) on a cobas 8000 e 801 module and a cobas pro module compared to positive results from competitor methods.On (b)(6) 2024 the result from competitor method 1 was 0.75 index (positive).On (b)(6) 2024 the result from competitor method 2 was 8.25 au/ml (positive).On (b)(6) 2024 the result from the e801 module was 0.71 coi (negative).On (b)(6) 2024 the result from the e801 module was 0.746 coi (negative).On (b)(6) 2024 the result from the cobas pro module was 0.712 coi (negative).On (b)(6) 2024 the result from competitor method 3 was 1.31 index (positive).
Additional Manufacturer Narrative
The patient sample was submitted for investigation.The following results were received: elecsys toxo igg: 139 iu/ml (positive) in-house neutralization assay: sample neutralizable elecsys toxo igg avidity: 67 avi% (low avidity) elecsys toxo igm: 0.752 coi (negative) recomline blot toxo igm: positive biorad platelia toxo igm: 3.25 od (positive) the customer's negative toxo igm results were reproduced with the elecsys assay, however, the results from 2 other manufacturers were positive.The sample was positive when tested for toxo igg.Based on the results produced during the investigation, the patient's sample is likely from an acute or recent infection with toxoplasma gondii which is captured by the elecsys toxo igg assay but not the elecsys toxo igm assay.Since a sample from an earlier date was not provided, it cannot be determined if a seroconversion with the elecsys toxo igm assay occurred and is already reversed in the sample provided or if the elecsys toxo igm assay did not capture the seroconversion.Product labeling states: "a negative toxo igm test result, also in combination with a positive toxo igg result, does not completely rule out the possibility of an acute infection with toxoplasma gondii: individuals at the early stage of acute infection may not exhibit detectable amounts of toxo igm antibodies.In some of these individuals an indeterminate or low positive result with the elecsys toxo igg assay may be found and indicate an early acute infection.A second sample should be tested e.G.Within 2 weeks.The detection of toxo igm and/or a significant increase of the elecsys toxo igg antibody titer in the second sample supports the diagnosis of acute toxoplasma infection.¿ in some individuals toxoplasma igm-specific antibodies may revert to non-reactive levels within few weeks after infection with t.Gondii." 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: 19145387
• Report Number: 1823260-2024-01215
• Device Sequence Number: 7443757
• Product Code: LGD
• UDI-Device Identifier: 04015630940318
• UDI-Public: 04015630940318
• Combination Product (Y/N): Y
• 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
• Report Date (Section B): 06/06/2024

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 Catalogue Number: 07028024190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 06/04/2024
• Initial Report FDA Received Date: 04/19/2024
• Supplement Report FDA Received Date: 06/06/2024
• 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 Age: 44 YR
• Patient Sex: Female