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	07/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas e602 module serial number was (b)(6).The provided calibration was the last relevant from 10-jun-2024 and it was within the expected ranges.Qc was within the assigned ranges on the day of the event.The sample was requested for investigation.
Event or Problem Description
We received an allegation about discrepant high results for 1 patient serum/plasma sample tested with elecsys toxo igm assay on a cobas 8000 cobas e602 immunoassay analyzer when compared to a competitor's analyzer (abbott) at another hospital.Initial result: 1.96 coi and interpreted as reactive (tested on e602).The customer sent out the sample to another hospital for re-testing as they have internal laboratory protocols in place to confirm the reactive result.No questionable result was reported outside the laboratory.On (b)(6) 2024 the 1st repeat result was non-reactive (tested on abbott's analyzer at another hospital).On (b)(6) 2024 the sample was repeated on the same e602 and the 2nd repeat result was 2.03 coi and interpreted as reactive.The 1st repeat result (non-reactive) was reported outside the laboratory.The physician suspected a toxoplasmosis infection.
Additional Manufacturer Narrative
On 12-aug-2024, the sample was received for investigation thawed.During the investigation, the sample was tested with the following: a) elecsys toxo igm and the result was 1.78 coi and interpreted as reactive.B) analysis with an interference-reducing substance: reactivity not based on interfering antibodies (igm-class) directed against the spatial structure of the elecsys standard ruthenium-label.C) biorad platelia toxo igm and the result was 0.513 od and interpreted as negative.D) elecsys toxo igg and the result was 316 iu/ml and interpreted as reactive.E) in-house neutralization assay and concluded that the sample was neutralizable.F) elecsys toxo igg avidity and revealed anti-toxo igg of gray-zone-avidity (79 avi-%).Based on the results obtained within this investigation and results provided by the customer, an acute infection with toxoplasma gondii was unlikely.The elecsys toxo igm result was considered false reactive.A general reagent problem was not found as the product labeling notes that false positive toxo igm test results can occur.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: 20034060
• Report Number: 1823260-2024-02438
• Device Sequence Number: 12361134
• Product Code: LGD
• UDI-Device Identifier: 04015630921485
• UDI-Public: 04015630921485
• Combination Product (Y/N): Y
• Initial Reporter Country: SA
• 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): 10/17/2024

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: 07/30/2024
• Device Catalogue Number: 04618858190
• Device Lot Number: 74065400
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/30/2024
• Supplement Date Received by Manufacturer: 09/23/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 10/17/2024
• 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 Age: 29 YR
• Patient Sex: Female
• Patient Race: Asian