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

Model Number TOXO IGM

Device Problem False Positive Result (1227)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/25/2023

Event Type  malfunction  

Manufacturer Narrative

Calibration signals from (b)(6) 2023 were within the expected ranges.Quality control results were acceptable.Na.

Event Description

The initial reporter alleged an increase in positive results for multiple patient samples tested on a particular reagent lot of elecsys toxo igm (toxo igm) on a cobas e 801 module, (b)(4).Reportedly, the patients are known for a negative toxo igm result and some samples were retested in a different laboratory using a competitor method resulting in a negative toxo igm result.Questionable result data was provided for 8 patient samples.Refer to the attachment for all relevant patient results.No questionable results were reported outside of the laboratory.

Manufacturer Narrative

No sample material could be provided 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.

• Brand Name: ELECSYS TOXO IGM
• Type of Device: 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: 16627747
• MDR Text Key: 312170694
• Report Number: 1823260-2023-00993
• Device Sequence Number: 1
• Product Code: LGD
• UDI-Device Identifier: 04015630940318
• UDI-Public: 04015630940318
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K162678
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/10/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: TOXO IGM
• Device Catalogue Number: 07028024190
• Device Lot Number: 671956
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/27/2023
• Initial Date FDA Received: 03/28/2023
• Supplement Dates Manufacturer Received: 04/28/2023
• Supplement Dates FDA Received: 05/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 31 YR
• Patient Sex: Female