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

Catalog Number	04618858190
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The toxo igm reagent that was used on 03-aug-2024 was expired and its lot number was 740654.The toxo igm reagent lot number used on 07-aug-2024 was 780868.The expiration date was 31-jan-2025.The cobas e411 serial number was (b)(6).On (b)(6) 2024 the 1st calibration of lot 780868 was performed and the calibration signals were within expected ranges.On (b)(6) 2024 the qc was performed with the expired lot reagent.On (b)(6) 2024 the qc was performed and it was within the assigned ranges.The sample was received for investigation on 28-aug-2024.The investigation is ongoing.
Event or Problem Description
We received an allegation about discrepant results for 1 patient's sample tested with elecsys toxo igm assay on a cobas e411 immunoassay analyzer (disk system) when copmapred to a competitor's analyzer (abbott) at another facility.Initial result: 1.60 coi and interpreted as reactive.The customer sent the sample to another laboratory to be repeated using an abbott instrument and the 1st repeat result was negative.On (b)(6) 2024 the customer repeated the sample and the 2nd repeat result was 1.68 coi and interpreted as reactive.No questionable results were reported outside the laboratory.The patient and the physician considered the negative result to be correct.
Additional Manufacturer Narrative
The customer alleged additional information about the patient: the patient was reportedly alleged to be medically treated based on the reactive elecsys toxo igm result and it was reportedly alleged that she showed side effects (nausea and vomiting) to the administered medication.The physical investigation of the sample showed that it was thawed but slightly cooled.During the investigation, the sample was tested using the following: elecsys toxo igm and the result was 1.84 coi and interpreted as reactive.Analysis with an interference-reducing substance: the reactivity was assessed as based on interfering antibodies (igm-class) directed against the spatial structure of the standard ruthenium label.Biorad platelia toxo igm and the result was negative.Elecsys toxo igg and the result was <0.130 iu/ml and interpreted as non-reactive.The reactivity observed for the sample with elecsys toxo igm was based on the interfering antibodies against the elecsys standard ruthenium label in the patient sample.The sample was non-reactive for elecsys toxo igg.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: 20090532
• Report Number: 1823260-2024-02493
• Device Sequence Number: 20732801
• Product Code: LGD
• UDI-Device Identifier: 04015630921485
• UDI-Public: 04015630921485
• Combination Product (Y/N): Y
• Initial Reporter Country: ID
• 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): 10/28/2024

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: 07/31/2024
• Device Catalogue Number: 04618858190
• Device Lot Number: 740654, 780868
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/05/2024
• Supplement Date Received by Manufacturer: 10/01/2024
• Initial Report FDA Received Date: 08/28/2024
• Supplement Report FDA Received Date: 10/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 32 YR
• Patient Sex: Female
• Patient Race: Asian