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	10/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter questioned the results for 2 patient samples tested for elecsys toxo igm (toxo igm) on a cobas e 411 analyzer (rack system).Patient 1: on (b)(6) 2023, the toxo igm result was 0.832 coi (borderline).On (b)(6) 2023, the toxo igm result was 0.891 coi (borderline).On (b)(6) 2023, the chemiluminescent immunoassay (clia) method toxo igm result was 4.3 ua/ml (negative).Patient 2: on (b)(6) 2023, the toxo igm result was 0.956 coi (borderline).On (b)(6) 2023, the toxo igm result was 1.02 coi (positive).On (b)(6) 2023, the toxo igm result was 1.02 coi (positive).
Additional Manufacturer Narrative
The e411 analyzer serial number was (b)(6).Calibration was last performed on (b)(6) 2023 with acceptable results.Qc was acceptable.The investigation is ongoing.
Additional Manufacturer Narrative
The reagent performs within specification.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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: 18006848
• Report Number: 1823260-2023-03423
• Device Sequence Number: 12408655
• Product Code: LGD
• UDI-Device Identifier: 04015630921485
• UDI-Public: 04015630921485
• 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): 10/31/2023

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 Expiration Date: 10/31/2023
• Device Catalogue Number: 04618858190
• Device Lot Number: 67194901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/04/2023
• Supplement Date Received by Manufacturer: 10/30/2023
• Initial Report FDA Received Date: 10/25/2023
• Supplement Report FDA Received Date: 10/31/2023
• 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 Age: 39 YR
• Patient Sex: Female