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	03/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Calibration and qc were acceptable.Investigation is ongoing.
Event or Problem Description
The initial reporter alleged an increased number of borderline or weakly positive results for an unspecified number of patient samples tested on a particular reagent lot of elecsys toxo igm (toxo igm) on a cobas e 801 module.Discrepant results for 1 patient sample were provided.Igm results: non-reactive when tested on previous samples, while the results were often borderline or positive when tested with the particular toxo igm reagent lot.No specific results were provided.It is not known if the questionable results were reported outside of the laboratory.The cobas e801 module serial number was (b)(4).
Additional Manufacturer Narrative
The patient sample was requested for investigation, but could not be provided.The investigation determined that no product issue was found and that the elecsys toxo igm reagent performed within specifications.

• 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: 16717909
• Report Number: 1823260-2023-01220
• Device Sequence Number: 20642274
• 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): 05/25/2023

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: 10/31/2023
• Device Model Number: TOXO IGM
• Device Catalogue Number: 07028024190
• Device Lot Number: 67195601
• 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: 03/16/2023
• Supplement Date Received by Manufacturer: 04/28/2023
• Initial Report FDA Received Date: 04/11/2023
• Supplement Report FDA Received Date: 05/25/2023
• 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