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	09/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter questioned positive results for 2 patient samples tested for elecsys toxo igg (toxo igg) on a cobas e 801 analytical unit.On (b)(6) 2022 patient 1 (id (b)(6)) result from the e801 analyzer was 82.1 iu/ml (positive).The result from the vidas method was 6.0 iu/ml (indeterminate).On (b)(6) 2022 patient 2 (id (b)(6)) result from the e801 analyzer was 34.2 iu/ml (positive) the result from the liaison diasorin method was < 3.0 iu/ml (negative).The result from the vidas (predetermination) method was 5.0 iu/ml (indeterminate).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.Sample material was requested for investigation.
Additional Manufacturer Narrative
Section d4, expiration date was updated.Both samples were received for investigation and tested with the elecsys toxo igg assay, an in-house neutralization assay, and a competitor toxo igg assay.The samples were also tested for elecsys toxo igg avidity and elecsys toxo igm.For patient 1: the elecsys toxo igg result was 83.8 iu/ml (positive).The sample was neutralizable (10.0% of remaining titer).Recomline blot toxo igg: positive.Elecsys toxo igg avidity: 92% (high avidity).Elecsys toxo igm: 0.222 coi (negative).For patient 2: the elecsys toxo igg result was 34.1 iu/ml (positive).The sample was neutralizable (10.7% of remaining titer).Recomline blot toxo igg: positive.Elecsys toxo igg avidity: 60% (low avidity).Elecsys toxo igm: 0.232 coi (negative).The customer's positive toxo igg results were reproduced during the investigation.Based on the results produced during the investigation, the samples were assessed to be correctly positive.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: 15881566
• Report Number: 1823260-2022-03793
• Device Sequence Number: 20173844
• Product Code: LGD
• UDI-Device Identifier: 04015630940301
• UDI-Public: 04015630940301
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• 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): 02/22/2023

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: 598234
• 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: 11/03/2022
• Supplement Date Received by Manufacturer: 02/02/2023
• Initial Report FDA Received Date: 11/29/2022
• Supplement Report FDA Received Date: 02/22/2023
• 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: 40 YR
• Patient Sex: Female