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	04/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 other text : na.
Event or Problem Description
The initial reporter stated, they received false positive results for an unspecified number of patient samples tested with elecsys toxo igm, on cobas e 801 module (b)(4).The customer stated, they have been receiving a higher number of false positive patient results with reagent lot 671956 and are submitting three times more samples for control measurement.The following data overview for the time period of october 2022 until march 2023 was provided by the customer: (b)(6) 2022: 20 patient samples.(b)(6) 2022: 14 patient samples.(b)(6) 2022: 14 patient samples.(b)(6) 2023 (previous reagent lot): 24 patient samples.(b)(6) 2023 (starting with new reagent lot): 43 patient samples.(b)(6) 2023 (reagent lot 6791956): 60 patient samples.No questionable results were reported outside of the laboratory.
Additional Manufacturer Narrative
No sample material was provided for investigation.Since no samples were available for investigation, the cause of the event could not be determined.Internal investigations have confirmed a decreased specificity for this reagent lot, still performing within the product specifications.The specificity is within the claimed range.The reagent performs within specification.The investigation did not identify a product problem.

• 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: 16827694
• Report Number: 1823260-2023-01419
• Device Sequence Number: 7180870
• 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): 05/15/2023

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: 04/03/2023
• Supplement Date Received by Manufacturer: 04/28/2023
• Initial Report FDA Received Date: 04/27/2023
• Supplement Report FDA Received Date: 05/15/2023
• 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