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

Catalog Number	07028024190
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The e801 module serial number was (b)(6).Calibration and qc were acceptable.The samples were requested for investigation.
Event or Problem Description
The initial reporter questioned the results for 6 patient samples tested for elecsys toxo igm (toxo igm) on a cobas e801 module.Of the data provided, the results for 4 patient samples were discrepant when compared to a competitor chemiluminescent immunoassay (clia) method.Patient id (b)(6) result from the e801 module was 1.28 coi (positive).The result from the competitor instrument was less than 3 ua/ml (negative).Patient id (b)(6) result from the e801 module was 1.13 coi (positive).The result from the competitor instrument was less than 3 ua/ml (negative).Patient id (b)(6) result from the e801 module was 0.86 coi (indeterminate).The result from the competitor instrument was less than 3 ua/ml (negative).Patient id (b)(6) result from the e801 module was 2.76 coi (positive).The result from the competitor instrument was 5 ua/ml (negative).No questionable results were reported outside of the laboratory.
Additional Manufacturer Narrative
The patient samples were received for investigation.The patient samples were tested with the elecsys toxo igg assay, the elecsys toxo igg avidity assay, the elecsys toxo igm assay, and the lineblot, recomline toxoplasma igm assay.Patient samples id (b)(6) were found to be negative with the elecsys toxo igg assay.Patient sample id (b)(6) was found to be positive with the elecsys toxo igg assay (1475 iu/ml).Patient sample id (b)(6) was tested with the elecsys toxo igg avidity assay.The result showed a high avidity (89%).Based on the toxo igg avidity result, an acute infection is unlikely and a remote state of infection is suspected for this patient sample.All 4 patient samples were tested with 2 reagent lots of the elecsys toxo igm assay (671949 and 740654).With reagent lot 671949: the customer's toxo igm results were reproduced.The results for all 4 patient samples were positive or indeterminate.With reagent lot 740654: only patient sample id (b)(6) was positive.The other 3 patient samples were negative.All 4 patient samples were tested with the lineblot, recomline toxoplasma igm assay.Patient samples id (b)(6) were found to be negative.Patient sample id (b)(6) was found to be positive.Based on the results of the investigation: patient samples id (b)(6) are considered to be false indeterminate/positive for elecys toxo igm due to a lower specificity of the reagent lot (71293601).Patient sample id (b)(6) contains persisting anti-toxo igm from a previous infection.Internal investigations have confirmed a decreased specificity for this reagent lot (71293601), still performing within the product specifications.The specificity is within the claimed range.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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 17789393
• Report Number: 1823260-2023-03044
• Device Sequence Number: 6455046
• Product Code: LGD
• UDI-Device Identifier: 04015630940318
• UDI-Public: 04015630940318
• Combination Product (Y/N): Y
• Initial Reporter Country: CO
• 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): 10/13/2023

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: 02/29/2024
• Device Catalogue Number: 07028024190
• Device Lot Number: 71293601
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/28/2023
• Supplement Date Received by Manufacturer: 10/12/2023
• Initial Report FDA Received Date: 09/21/2023
• Supplement Report FDA Received Date: 10/13/2023
• 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