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

Catalog Number	04618858190
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the customer's cobas e411 rack is (b)(6).The reported patient sample is not available for investigation.The customer would like to send a new sample from the patient.The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable elecsys toxo igm (toxo igm) results from one patient sample tested on the cobas e411 rack.The initial result was not reported outside of the laboratory.The patient sample was sent out and was analyzed using the chemiluminescent immunoassay (clia) laboratory method.The repeat result was on (b)(6) 2023, the initial result from the analyzer was "non-reactive" with a cut-off index (coi) of 0.256.On (b)(6) 2023, the first repeat result from the analyzer was "reactive" with a coi of 1.53.On (b)(6) 2023, the second repeat result from the analyzer was "reactive" with a coi of 1.51.On (b)(6) 2023, the third repeat result from the clia method was "non-reactive" with a coi of 0.08.
Additional Manufacturer Narrative
No patient sample was available for investigation.The investigation reviewed the last calibration from 04-apr-2023; the results were within specifications.Product labeling states "calibration frequency: calibration must be performed once per reagent lot using toxigm cal1, toxigm cal2 and fresh reagent (i.E.Not more than 24 hours since the reagent kit was registered on the analyzer).Calibration interval may be extended based on acceptable verification of calibration by the laboratory.Renewed calibration is recommended as follows: ¿ after 1 month (28 days) when using the same reagent lot ¿ after 7 days (when using the same reagent kit on the analyzer) ¿ as required: e.G.Quality control findings outside the defined limits ¿ more frequently when this is required by pertinent regulations." the investigation reviewed the qc recovery on the relevant days of measurement; the results were within specifications.An extensive investigation has confirmed a lower specificity for reagent lot 671956 (same production event as for lot 671949) compared to the previous lot 652164, showing an increase of approx.1.2 % in the amount of reactive elecsys toxo igm results.The determined specificity of the affected lot 671956 was lower compared with the specificity claims in the method sheet, however, within the lower confidence limits of study 1 and study 2 as stated in the method comparison section of the method sheet.Product labeling states "study 1: n = 785; relative sensitivity = 95.3 % (162/170); lower confidence limit = 91.7 %; relative specificity = 98.8 % (595/602); lower confidence limit 97.8 %; study 2: n = 390; relative sensitivity = 98.8 % (83/84); lower confidence limit = 94.5 %; relative specificity = 99.5 % (294/295); lower confidence limit 98.4 %".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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 17503050
• Report Number: 1823260-2023-02584
• Device Sequence Number: 6374829
• Product Code: LGD
• UDI-Device Identifier: 04015630921485
• UDI-Public: 04015630921485
• Combination Product (Y/N): Y
• Initial Reporter Country: CO
• 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): 09/12/2023

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: 04618858190
• Device Lot Number: ACK5P000002SK7NCAS
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/17/2023
• Supplement Date Received by Manufacturer: 08/17/2023
• Initial Report FDA Received Date: 08/10/2023
• Supplement Report FDA Received Date: 09/12/2023
• 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: 35 YR
• Patient Sex: Female