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

Model Number IL-6

Device Problems Use of Device Problem (1670); High Test Results (2457); Low Test Results (2458); Non Reproducible Results (4029)

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

Event Date 06/25/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.H3 other text : na.

Event Description

There was an allegation of questionable elecsys il-6 results for 2 samples drawn from the patient at the same time and run on two cobas 8000 - cobas e 602 modules.On (b)(6)2023, sample 1 had an initial result of 1.91 pg/ml on analyzer serial number (b)(6) in the laboratory reporting the issue.On(b)(6)2023, the sample was repeated on the same analyzer and the result was 28.8 pg/ml.The sample was also repeated on analyzer serial number (b)(6) in a different laboratory and the result was 33.82 pg/ml.On (b)(6)-2023, sample 2 had an initial result of 130.8 pg/ml on analyzer serial number (b)(6) in the other laboratory.On (b)(6)-2023, the sample was repeated on the same analyzer and the result was 180.6 pg/ml.The sample was also repeated on the analyzer serial number (b)(6) in the reporting laboratory and the result was 190.6 pg/ml.

Manufacturer Narrative

The root cause of the event was found to be consistent with pre-analytical sample handling issues.The investigation did not identify a product problem.

• 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: 17385147
• MDR Text Key: 320250403
• Report Number: 1823260-2023-02452
• Device Sequence Number: 1
• Product Code: QLC
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 08/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IL-6
• Device Catalogue Number: 05109442190
• Device Lot Number: 62092801
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/10/2023
• 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