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	08/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Sample material was requested for investigation.The investigation is ongoing.
Event or Problem Description
The initial reporter questioned positive results for 1 patient tested for elecsys toxo igg (toxo igg) on a cobas e 801 analytical unit.On (b)(6) 2022 the patient had a toxo igg result from a non-roche method of 2.1 ui/ml (negative).The result from the e801 module was approximately 40 iu/ml (positive).On (b)(6) 2022 the patient had a toxo igg result from a non-roche method of 2.3 iu/ml (negative).The result from the e801 module was 42 iu/ml (positive).Western blot testing was performed on this sample and the presence of igg was not confirmed.On (b)(6) 2022 the result from the e801 module was 39.6 iu/ml (positive).No questionable results were reported outside of the laboratory.The e801 analyzer serial number was (b)(4).
Additional Manufacturer Narrative
Calibration and qc were acceptable.The sample from 19-aug-2022 was received for investigation.The following results were obtained during the investigation: elecsys toxo igg: 47.0 iu/ml (positive).The sample was neutralizable: 8.6% of remaining titer.Recomline blot toxo igg: borderline with a weak gra7-band.Elecsys toxo igg avidity: 86% (high avidity).Elecsys toxo igm: 0.275 coi (negative).Based on these results, the investigation determined the sample was correctly positive.Based on the toxo igm and toxo igg avidity results an acute infection of the patient is not likely and a remote state of infection is suspected.The reagent performed within specification.The investigation did not identify a product problem.

• 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: 16185801
• Report Number: 1823260-2023-00141
• Device Sequence Number: 2303610
• 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): 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): 02/07/2023

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: 12/31/2022
• Device Catalogue Number: 07028008190
• Device Lot Number: 59823401
• 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: 12/27/2022
• Supplement Date Received by Manufacturer: 02/02/2023
• Initial Report FDA Received Date: 01/17/2023
• Supplement Report FDA Received Date: 02/07/2023
• 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