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	06/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received discrepant results for two samples collected from the same patient and tested with the elecsys toxo igm immunoassay on a cobas e 411 immunoassay analyzer.The first sample resulted in a toxo igm value of 4.30 coi (reactive) when tested on the e411 analyzer.The 4.30 coi (reactive) value was reported outside of the laboratory.The sample was sent to another laboratory for testing with an unknown toxo igm method, resulting in a negative result.A second sample was collected from the patient and resulted in a toxo igm value of 4.28 coi (reactive) when tested on the e411 analyzer.The sample was sent to another laboratory for testing with an unknown toxo igm method, resulting in a negative result.The serial number of the e411 analyzer is (b)(4).
Additional Manufacturer Narrative
Two samples from the patient were provided for investigation.The customer's elecsys toxo igm results could be reproduced.The samples were non-reactive for elecsys toxo igg.Based on recomline toxo igm immunoblot, a toxo p30 antigen band was detected.A true reactivity to toxo p30 could not be excluded based on the blot results.The investigation could not identify a product problem.The cause of the event could not be determined.An early toxoplasma infection could not excluded.

• 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 14790901
• Report Number: 1823260-2022-01840
• Device Sequence Number: 4843715
• Product Code: LGD
• UDI-Device Identifier: 04015630921485
• UDI-Public: 04015630921485
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 09/12/2022

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: 590340
• 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: 06/01/2022
• Supplement Date Received by Manufacturer: 08/23/2022
• Initial Report FDA Received Date: 06/23/2022
• Supplement Report FDA Received Date: 09/12/2022
• 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