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

Model Number	TOXO IGM
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable reactive elecsys toxo igm immunoassay results for 1 patient on a cobas e 602 module compared to a cobas 6000 system and a minividas analyzer.On (b)(6) 2022, the e602 toxo igm result was 1.62 coi, interpreted as reactive.On (b)(6) 2022, the patient was sent to another laboratory.A new sample was collected and run on a cobas 6000 analyzer and a minividas analyzer.The cobas 6000 toxo igm result was 1.53 coi, interpreted as reactive.The minividas toxo igm result was 0.05 coi, interpreted as non-reactive.No questionable results were reported outside of the laboratory.The e602 analyzer serial number is (b)(4).The cobas 6000 system serial number was requested but not provided.
Additional Manufacturer Narrative
The patient had an additional sample collected and tested for toxo igm on the same e602 analyzer.The result was 1.34 coi, interpreted as reactive.The date of sample collection and the date of testing were requested but not provided.The investigation is ongoing.
Additional Manufacturer Narrative
The calibration and qc recovery data provided was acceptable.A patient sample was submitted for investigation.It was determined that the patient sample contained interfering antibodies the to ruthenium component of the toxo igm reagent.The reactive toxo igm result was confirmed to be false.Per product labeling, "in rare cases, interference due to extremely high titers of antibodies to immunological components, streptavidin or ruthenium can occur.These effects are minimized by suitable test design." the reagent was found to be performing within specification.

• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16531531
• Report Number: 1823260-2023-00786
• Device Sequence Number: 7170670
• Product Code: LGD
• UDI-Device Identifier: 04015630921485
• UDI-Public: 04015630921485
• 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): N
• 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): 06/29/2023

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 Model Number: TOXO IGM
• Device Catalogue Number: 04618858190
• Device Lot Number: 62848100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2023
• Supplement Date Received by Manufacturer: 04/13/2023; 06/01/2023
• Initial Report FDA Received Date: 03/13/2023
• Supplement Report FDA Received Date: 05/03/2023; 06/29/2023
• 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: Female