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	03/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation about discrepant reactive results for 2 patients' samples tested with elecsys toxo igm assay on a cobas 6000 e601 module serial number (b)(4) when sample 1 was compared to elecsys toxo igm reagent with a different lot number and sample 2 was compared to a non-roche analyzer.The following results were obtained: sample 1: initial result: non-reactive (0.283 coi) (test performed (b)(6) 2023 with lot number 658248.This result is considered correct.).Repeat result: was reactive (1.08 coi) (tested with lot number 671949 and considered incorrect).Sample 2: initial result: reactive (1.09 coi) (tested with lot number 671949 and considered incorrect) repeat result: non-reactive (< 3.0 au/ml) (tested on a diasorin analyzer).No erroneous result was reported outside the laboratory.The elecsys toxo igm reagent lot number in question was with an expiration date of oct-2023.The elecsys toxo igm reagent lot number used for the initial result of sample 1 (non-reactive) was 658248.The expiration date was not provided.
Additional Manufacturer Narrative
Calibration and qc were performed and they were acceptable.Investigation is ongoing.H3 : na.
Additional Manufacturer Narrative
The patient samples were requested for investigation, but could not be provided.The investigation determined that the reagent performed within specifications.

• 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: 16765128
• Report Number: 1823260-2023-01315
• Device Sequence Number: 6182024
• Product Code: LGD
• UDI-Device Identifier: 04015630921485
• UDI-Public: 04015630921485
• 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): 05/25/2023

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 Model Number: TOXO IGM
• Device Catalogue Number: 04618858190
• Device Lot Number: 671949
• 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: 03/28/2023
• Supplement Date Received by Manufacturer: 04/28/2023
• Initial Report FDA Received Date: 04/18/2023
• Supplement Report FDA Received Date: 05/25/2023
• 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