MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS TOXO IGM; ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII

Catalog Number	07028024190
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The e801 module serial number is (b)(6).Calibration and qc were acceptable.The investigation is ongoing.
Event or Problem Description
The initial reporter questioned positive results for "several" patient samples tested for elecsys toxo igm (toxo igm) on a cobas e801 module.Data was provided for 37 patient samples tested between (b)(6) 2023 and (b)(6) 2023.Of this data, the results for 33 patient samples were positive (results greater than 1.0 coi).The customer allegedly believes the results are falsely positive if no evolution is seen in the igm or igg results after more than 14 days or if the toxo igm result from a different method is negative.No comparison data was provided.The following are examples of positive results for 3 patient samples: on (b)(6) 2023 patient 1 (id (b)(6)) result was reportedly 2.66 coi (positive).On (b)(6) 2023 patient 2 (id (b)(6)) result was reportedly 5.61 coi (positive).On (b)(6) 2023 patient 3 (id (b)(6)) result was reportedly 1.13 coi (positive).
Additional Manufacturer Narrative
No sample material was available for investigation.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.
Additional Manufacturer Narrative
Section d4, expiration date was updated.

• 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 17652616
• Report Number: 1823260-2023-02823
• Device Sequence Number: 7371166
• Product Code: LGD
• UDI-Device Identifier: 04015630940318
• UDI-Public: 04015630940318
• Combination Product (Y/N): Y
• Initial Reporter Country: BE
• 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,Followup
• Report Date (Section B): 10/02/2023

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 Catalogue Number: 07028024190
• Device Lot Number: 671956
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/07/2023
• Supplement Date Received by Manufacturer: 09/18/2023; 09/15/2023
• Initial Report FDA Received Date: 08/30/2023
• Supplement Report FDA Received Date: 09/26/2023; 10/02/2023
• 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: 30 YR
• Patient Sex: Female