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

Model Number	TOXO IGM
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.H3 other text : na.
Event or Problem Description
The initial reporter received questionable elecsys toxo igm (toxo igm) results from an unspecified number of patient samples tested on the cobas 8000 e 801 msb/msbl with serial number (b)(4).The reporter complained of an increasing number of borderline or weakly positive results for toxo igm with the reported lot number.The patient sample was rerun using a different reagent lot number and on a vidas analyzer.The reporter was able to provide one example of a questionable result.The initial result was not reported outside of the laboratory.The initial result using reagent lot number 671956 is 2.2.The first repeat result from the vidas analyzer was "negative".The second repeat result using reagent lot number 652164 is 0.247.The repeat result was deemed correct. .
Additional Manufacturer Narrative
The patient sample was not received for investigation.The cause of the event could not be determined.Internal investigations have confirmed a decreased specificity for this reagent lot, still performing within the product specifications.The specificity is within the claimed range.Product labeling states "method comparison - relative sensitivity and specificity after resolution: study 1 n = 785; relative sensitivity % - 95.3 (162/170); lower confidence limit % - 91.7; relative specificity % - 98.8 (595/602); lower confidence limit % - 97.8.Study 2 n = 390; relative sensitivity % - 98.8 (83/84); lower confidence limit % - 94.5; relative specificity % - 99.7 (294/295); lower confidence limit % - 98.4." the reagent performs within specification.The investigation did not identify a product problem.

• Brand Name: ELECSYS TOXO IGM
• 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: 16732289
• Report Number: 1823260-2023-01247
• Device Sequence Number: 20510806
• Product Code: LGD
• UDI-Device Identifier: 04015630940318
• UDI-Public: 04015630940318
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K162678
• 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): 05/23/2023

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 Model Number: TOXO IGM
• Device Catalogue Number: 07028024190
• Device Lot Number: 671956
• 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: 03/21/2023
• Supplement Date Received by Manufacturer: 04/28/2023
• Initial Report FDA Received Date: 04/13/2023
• Supplement Report FDA Received Date: 05/23/2023
• 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: Unknown