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

Catalog Number 07028008190

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/29/2022

Event Type  malfunction  

Event 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).

Manufacturer Narrative

Calibration and qc were acceptable.Sample material was requested for investigation.

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
• Type of Device: 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
• MDR Text Key: 307800646
• Report Number: 1823260-2022-03793
• Device Sequence Number: 1
• Product Code: LGD
• UDI-Device Identifier: 04015630940301
• UDI-Public: 04015630940301
• Combination Product (y/n): N
• Reporter Country Code: TC
• PMA/PMN Number: K073501
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 02/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Sex: Female