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	03/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation reviewed the customer's calibration results and determined the results were acceptable.The investigation reviewed the provided qc results, which were not from the date of the event, and the results were within acceptable ranges.The sample from the patient was requested for further investigation, but no samples were available.Based on the provided information, the investigation did not identify a product problem.The cause of the event could not be determined.
Event or Problem Description
The initial reporter received questionable elecsys toxo igm results for one patient tested on a cobas 6000 e 601 module serial number 32l6-09.On (b)(6) 2022, the patient's initial elecsys toxo igm result was reported outside the laboratory.On (b)(6) 2022, the patient went to a reference center for further testing.On (b)(6) 2022, the patient had a new sample collected and the customer performed testing with the e 601 module.On (b)(6) 2022, the patient's initial elecsys toxo igm result was positive.The specific value was requested but not provided.On (b)(6) 2022, the patient's toxo igm result at the reference center and by "cmia" methodology was negative.On (b)(6) 2022, the patient's elecsys toxo igm result was 5.7 coi positive.

• 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 14516872
• Report Number: 1823260-2022-01500
• Device Sequence Number: 5628928
• Product Code: LGD
• UDI-Device Identifier: 04015630921485
• UDI-Public: 04015630921485
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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
• Report Date (Section B): 05/26/2022

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: 11/30/2022
• Device Model Number: TOXO IGM
• Device Catalogue Number: 04618858190
• Device Lot Number: 59034001
• 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: 05/05/2022
• Initial Report FDA Received Date: 05/26/2022
• 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 Age: 31 YR
• Patient Sex: Female