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

Model Number IL-6

Device Problems Incorrect Measurement (1383); High Test Results (2457)

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

Event Date 05/28/2022

Event Type  malfunction  

Manufacturer Narrative

The il-6 version 2 reagent is not cleared or approved for use in the us.The field service engineer performed a general cleaning, cleaned the sipper and procell and cleancell cups, cleaned the pipettes and wash stations, cleaned the prewash area, and replaced the pinch valves.The patient's sample was requested for an investigation.The investigation is ongoing.

Event Description

The initial reporter received unexpected high elecsys il-6 version 1 results for one patient tested on a cobas 6000 e 601 module serial number (b)(4).It was unknown if the patient's initial il-6 result was reported outside the laboratory as the initial il-6 result did not match the patient's clinical history.The customer performed a calibration verification and qc with acceptable results.The customer reportedly performed repeat testing with the sample with the il-6 version 1 assay and the il-6 version 2 assay.It was reported the reprocessing of the sample with il-6 version 2 generated normal values.The patient's initial il-6 version 1 result was 21.23 pg/ml.The patient's initial il-6 version 2 result was 1.50 pg/ml.The patient's repeat il-6 version 1 result was 21.25 pg/ml.The patient's repeat il-6 version 2 result was allegedly the same result.The il-6 version 1 reagent lot number was 49651501 with an expiration date of 30-nov-2022.The il-6 version 2 reagent lot number was 58703201 with an expiration date of 31-jan-2024.

Manufacturer Narrative

The investigation did not identify a product problem.The cause of the event could not be determined as sample material was available.The customer was using a clotting time of 15 minutes which is usually too short and may lead to preanalytic issues.

• 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: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15115300
• MDR Text Key: 304711970
• Report Number: 1823260-2022-02206
• Device Sequence Number: 1
• Product Code: QLC
• Combination Product (y/n): N
• Reporter Country Code: ES
• 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
• Report Date: 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2022
• 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: 49651502
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/07/2022
• 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