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	04/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable elecsys toxo igm results from the cobas pure e 402 analytical unit.The initial result was 14.9 coi (reactive).The repeat result was reactive.No numeric result was provided.On (b)(6) 2024, the same sample was tested using diasorin liaison toxo igm and the result was <3.0 s/co (non-reactive).On (b)(6) 2024, the same sample was tested using abbott alinity toxo igm and the result was 0.160 index (non-reactive).The questionable results were reported outside of the laboratory.
Additional Manufacturer Narrative
The cobas pure e 402 analytical unit serial number was (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
A second sample from the patient had the following results: elecsys toxo igm: 6.18 coi (reactive).Diasorin liaison xl toxo igm: <3.0 au/ml (non-reactive).Abbott alinity toxo igm: 0.140 index (non-reactive).This sample from the patient was submitted for investigation and the customer¿s elecsys toxo igm results were reproducible.Based on the results obtained within the investigation and results provided by the customer, the reactive elecsys toxo igm result was found to be incorrect due to interference.The specific nature of the interference could not be determined.Due to the relative specificity documented in product labeling that false positive results can occur, the reagent was found to be performing within specification.

• 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: 19340428
• Report Number: 1823260-2024-01478
• Device Sequence Number: 7143445
• Product Code: LGD
• UDI-Device Identifier: 04015630940318
• UDI-Public: 04015630940318
• Combination Product (Y/N): Y
• Initial Reporter Country: PL
• 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): 07/31/2024

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: 07028024190
• Device Lot Number: 740657
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/25/2024
• Supplement Date Received by Manufacturer: 07/26/2024
• Initial Report FDA Received Date: 05/17/2024
• Supplement Report FDA Received Date: 07/31/2024
• 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 Sex: Female