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	02/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer's last calibration with lot 652164 on (b)(6) 2022 and lot 671956 on (b)(6) 2023 were found within the expected ranges.The quality control overview was acceptable.Specific quality control recoveries were only provided for 19-may-2023.The patient sample was requested for investigation but could not be provided.The investigation could not identify a product problem.The cause of the event could not be determined.H3 other text : na.
Event or Problem Description
The initial reporter stated they received questionable positive results for three samples collected from the same patient and tested with the elecsys toxo igm assay on a cobas e 801 analytical unit, serial number (b)(6).First sample, collected on (b)(6) 2023 and tested with toxo igm reagent lot 652164: on (b)(6) 2023, the sample initially resulted in a toxo igm value of 2.43 coi (reactive).Second sample, collected on (b)(6) 2023 and tested with toxo igm reagent lot 671956: on (b)(6) 2023, the sample initially resulted in a toxo igm value of 1.90 coi (reactive).At an unknown date, the sample was also tested with an unknown competitor chemiluminescent assay, resulting in a non-reactive toxo igm result.Third sample, collected on (b)(6) 2023 and tested with toxo igm reagent lot 671956: on (b)(6) 2023, the sample initially resulted in a toxo igm value of 2.26 coi (reactive).The questionable results were reported outside of the laboratory.

• 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: 17145450
• Report Number: 1823260-2023-01995
• Device Sequence Number: 14850375
• Product Code: LGD
• UDI-Device Identifier: 04015630940318
• UDI-Public: 04015630940318
• 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
• Report Date (Section B): 06/16/2023

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: 07/31/2023
• Device Model Number: TOXO IGM
• Device Catalogue Number: 07028024190
• Device Lot Number: 65216401, 671956
• 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: 05/24/2023
• Initial Report FDA Received Date: 06/16/2023
• 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 Age: 37 YR
• Patient Sex: Female