MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS IL 6; INTERLEUKIN 6

Model Number IL-6

Device Problem Low Test Results (2458)

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

Event Date 08/23/2021

Event Type  malfunction  

Manufacturer Narrative

Na.

Event Description

The initial reporter stated they received discrepant results for 52 patient samples tested with the elecsys il-6 assay on a cobas e 411 immunoassay analyzer.The results did not compare to results obtained with competitor methods.It was asked, but it is not known if any incorrect results were reported outside of the laboratory.The first sample initially resulted in an il-6 value of < 1.50 pg/ml accompanied by a data flag when tested on the e411.The sample was repeated twice using the vector-best elisa method and the siemens immulite analyzer.With each competitor method, the result was 300 pg/ml.The sample was diluted and repeated on the e411 analyzer on (b)(6) 2021, resulting in a value of < 1.50 pg/ml accompanied by a data flag.The second sample initially resulted in an il-6 value of 8.45 pg/ml when tested on the e411.The sample was repeated twice using the vector-best elisa method and the siemens immulite analyzer.With each competitor method, the result was 300 pg/ml.The sample was diluted and repeated on the e411 analyzer on (b)(6) 2021, resulting in a value of 5.84 pg/ml.The reporter later provided data for an additional 50 patient samples with discrepant il-6 results.Data from these samples (samples 3 -52).These samples are from patients with a confirmed diagnosis of covid-19.The serial number of the e411 analyzer is (b)(4).

Manufacturer Narrative

Refer to the updated attachment pt-62302.Pdf which includes one additional sample comparison (sample 53).Information highlighted in yellow represents the updated patient information received.No results from the roche il-6 assay were reported outside of the laboratory.Any treatment decisions of patients were based on the results measured with the competitor methods.Medwatch field b3.Has been updated.

Manufacturer Narrative

The investigation could not identify a product problem.The cause of the event could not be determined.No samples were available for investigation.

• Brand Name: ELECSYS IL 6
• Type of Device: INTERLEUKIN 6
• 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 12508458
• MDR Text Key: 273138205
• Report Number: 1823260-2021-02757
• Device Sequence Number: 1
• Product Code: QLC
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: EUA
• 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,Followup
• Report Date: 12/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: IL-6
• Device Catalogue Number: 05109442190
• Device Lot Number: 54022601
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2021
• 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