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 08/19/2022

Event Type  malfunction  

Manufacturer Narrative

Sample material was requested for investigation.The investigation is ongoing.

Event 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).

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
• 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: 16185801
• MDR Text Key: 308923044
• Report Number: 1823260-2023-00141
• Device Sequence Number: 1
• Product Code: LGD
• UDI-Device Identifier: 04015630940301
• UDI-Public: 04015630940301
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 02/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2023
• 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: 59823401
• 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 Sex: Female