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	10/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the e411 analyzer is (b)(6).The serial number of the unknown roche analyzer is (b)(6).The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received questionable results for one patient sample tested with elecsys toxo igm on a cobas e411 rack and a second unknown roche analyzer.The sample initially resulted in a toxo igm value of 1.24 coi (reactive) when tested on the e411 analyzer on (b)(6) 2023.The sample was repeated on a second unknown roche analyzer on (b)(6) 2023, resulting in a toxo igm value of 1.25 coi (reactive).The sample was sent to a reference laboratory and tested using an unknown method, resulting in a toxo igm value of 0.07 ui/ml (negative).The sample was also sent to a second reference laboratory where it was tested using an unknown method, resulting in a toxo igm value of 0.06 index (non-reactive).
Additional Manufacturer Narrative
Calibration and controls were acceptable.The reagent performed within specifications.The investigation could not identify a product problem.The cause of the event could not be determined.A sample from the patient was not available for investigation.

• 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: 18194723
• Report Number: 1823260-2023-03754
• Device Sequence Number: 15382374
• Product Code: LGD
• UDI-Device Identifier: 04015630921485
• UDI-Public: 04015630921485
• 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): 01/17/2024

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: 02/29/2024
• Device Catalogue Number: 04618858190
• Device Lot Number: 71292901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/01/2023
• Supplement Date Received by Manufacturer: 01/17/2024
• Initial Report FDA Received Date: 11/22/2023
• Supplement Report FDA Received Date: 01/17/2024
• 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: Unknown