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 04/26/2021

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Unique device identifier (udi) (b)(4).The investigation is ongoing.

Event Description

The initial reporter received questionable elecsys il 6 results for one patient tested on a cobas e411 disk serial number (b)(4).The patient's initial il six (6) result was not reported outside the laboratory.The customer performed repeat testing with a vector-best elisa analyzer and the cobas e411 disk.On (b)(4) 2021, the patient's elecsys initial il six (6) result was 1.50 pg/ml with a data flag.The patient's il 6 result with the same sample on the vector-best elisa analyzer was 300 pg/ml.On (b)(6) 2021, the patient's repeat elecys il six (6) result with the same sample on the cobas e411 disk was 1.77 pg/ml.On (b)(6) 2021, the patient had a new sample collected and the patient's elecsys il six (6) result on a cobas e411 disk was 2.60 pg/ml.

Manufacturer Narrative

The customer's calibration results were ok but lower than the expected ranges.The customer's qc results from (b)(6)2021 were ok.The investigation reviewed the system's alarm trace and no critical alarms were discovered.Two patient samples were provided for an investigation.The investigation discovered the patient's sample collected on (b)(6)2021 was hemolytic.The investigation tested the provided samples and the customer's results were reproduced.No interfering factor was found in either of the provided samples.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS IL 6
• Type of Device: INTERLEUKIN 6
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 11840589
• MDR Text Key: 251152583
• Report Number: 1823260-2021-01477
• Device Sequence Number: 1
• Product Code: QLC
• Combination Product (y/n): N
• PMA/PMN Number: EUA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 06/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: IL-6
• Device Catalogue Number: 05109442190
• Device Lot Number: 49651501
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1