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	11/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable elecsys toxo igm immunoassay results for 1 patient sample on a cobas e 411 immunoassay analyzer.On 03-nov-2023, sample 1 had a toxo igm result of 1.22 coi, interpreted as positive.On (b)(6) 2023, the sample was repeated on another unknown analyzer and the result was 0.10 coi, interpreted as negative.
Additional Manufacturer Narrative
Four additional sets of questionable toxo igm patient sample results were provided.On (b)(6) 2023, sample 2 had a toxo igm result of 0.973 coi, interpreted as indeterminate.On (b)(6) 2023, the sample was repeated on another unknown analyzer and the result was 0.09 index, interpreted as non-reactive.On (b)(6) 2023, sample 3 had a toxo igm result of 2.51 coi, interpreted as reactive.On (b)(6) 2023, the sample was repeated on another unknown analyzer and the result was 0.70 index, interpreted as indeterminate.On (b)(6) 2023, sample 4 had a toxo igm result of 2.26 coi, interpreted as reactive.On (b)(6) 2023, the sample was repeated on another unknown analyzer and the result was 0.05 index, interpreted as non-reactive.On (b)(6) 2023, sample 5 had a toxo igm result of 1.12 coi, interpreted as reactive.On (b)(6) 2023, the sample was repeated on another unknown analyzer and the result was 0.05 index, interpreted as non-reactive.Calibration was last performed on (b)(6) 2023.The investigation is ongoing.
Additional Manufacturer Narrative
Calibration was last performed on 01-nov-2023.Samples from patient 1, 2, and 3 were provided for investigation.The investigation was able to reproduce the customer's results.The investigation did not identify a product problem.
Additional Manufacturer Narrative
Additional patient results were provided on (b)(6) 2024, (b)(6) 2024, and (b)(6) 2024.The new results were produced from reagent lot 740654.The expiration date was not provided.The exact dates of testing in (b)(6) 2024 were not provided.On (b)(6) 2024, sample 1 had a toxo igm result of 1.17 coi, interpreted as reactive.In (b)(6) 2024, sample 2 had a toxo igm result of 0.965 coi, interpreted as borderline.On (b)(6) 2024, sample 2 was tested four times for toxo igm and the results were 0.236 coi, 0.231 coi, 0.241 coi, and 0.236 coi, all interpreted as non-reactive.In (b)(6) 2024, sample 3 had a toxo igm result of 2.10 coi, interpreted as reactive.On (b)(6) 2024, sample 3 was tested twice for toxo igm and the results were 2.16 coi and 2.16 coi, both interpreted as reactive.In (b)(6) 2024, sample 4 had a toxo igm result of 2.30 coi, interpreted as reactive.On (b)(6) 2024, sample 4 had a toxo igm result of 2.23 coi, interpreted as reactive.In (b)(6) 2024, sample 5 had a toxo igm result of 1.11 coi, interpreted as reactive.On (b)(6) 2024, sample 5 was tested four times for toxo igm and the results were 0.19 coi, 0.185 coi, 0.187 coi, and 0.182 coi, all interpreted as non-reactive.The calibration data provided was acceptable.The samples were requested for investigation.The investigation is ongoing.

• 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: 18344375
• Report Number: 1823260-2023-04065
• Device Sequence Number: 5531801
• Product Code: LGD
• UDI-Device Identifier: 04015630921485
• UDI-Public: 04015630921485
• Combination Product (Y/N): Y
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/17/2024

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: 02/29/2024
• Device Catalogue Number: 04618858190
• Device Lot Number: 71292901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/21/2023
• Supplement Date Received by Manufacturer: 12/21/2023; 02/06/2024; 03/28/2024
• Initial Report FDA Received Date: 12/18/2023
• Supplement Report FDA Received Date: 12/22/2023; 02/29/2024; 04/17/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: FOLIC ACID (PATIENT 2)
• Patient Age: 34 YR
• Patient Sex: Female