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

Catalog Number	07028008190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Calibration was performed on 24-sep-2022 and 28-oct-2022 and was acceptable.The sample was not available for further investigation.The investigation did not identify a product problem.The root cause of the event could not be determined.
Event or Problem Description
There was an allegation of questionable elecsys toxo igg immunoassay results for 1 patient sample on a cobas e 801 analytical unit compared to an abbott alinity analyzer and a biomérieux vidas analyzer.On (b)(6) 2022, the initial toxo igg result was 50.70 iu/ml, interpreted as reactive.On (b)(6) 2022, the sample was repeated and the result was 56.90 iu/ml, interpreted as reactive.The sample was tested on an abbott alinity analyzer and the result was 1.4 iu/ml, interpreted as non-reactive.The sample was also tested on a biomérieux vidas analyzer and the result was 2 iu/ml, interpreted as non-reactive.No questionable results were reported outside of the laboratory.The e801 serial number is (b)(4).

• Brand Name: ELECSYS TOXO IGG
• 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: 15978366
• Report Number: 1823260-2022-04009
• Device Sequence Number: 6997521
• Product Code: LGD
• UDI-Device Identifier: 04015630940301
• UDI-Public: 04015630940301
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K073501
• 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
• Report Date (Section B): 12/14/2022

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 Expiration Date: 03/31/2023
• Device Catalogue Number: 07028008190
• Device Lot Number: 63024901
• 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: 11/23/2022
• Initial Report FDA Received Date: 12/14/2022
• 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: Unknown