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	05/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The calibration and qc data were acceptable.The investigation is ongoing.
Event or Problem Description
There was an allegation of a false positive toxo igm elecsys result from cobas 6000 e601 module serial number (b)(6).The results were 1.03 coi and 1.04 coi (reactive).The customer sent the sample to another laboratory using clia methodology and the result was negative and deemed correct.The questionable result was not reported outside of the laboratory.
Additional Manufacturer Narrative
As no sample material was available, further investigation was not possible.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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: 16962095
• Report Number: 1823260-2023-01688
• Device Sequence Number: 5392930
• Product Code: LGD
• UDI-Device Identifier: 04015630921485
• UDI-Public: 04015630921485
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 06/29/2023

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: 04618858190
• Device Lot Number: 67194901
• 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: 05/05/2023
• Supplement Date Received by Manufacturer: 06/01/2023
• Initial Report FDA Received Date: 05/19/2023
• Supplement Report FDA Received Date: 06/29/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: FEMINIS (VITAMIN COMPLEX THAT CONTAINS BIOTIN).
• Patient Age: 32 YR
• Patient Sex: Female