MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS INSULIN; IMMUNOREACTIVE INSULIN TEST SYSTEM

Catalog Number 07027559190

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).

Event Description

The customer submitted 2 samples from one patient to be tested for elecsys insulin (insulin) on a cobas e801 module.The customer is not using the elecsys insulin reagent yet but had tested one of the patient samples by the fujirebio method.During the investigation, discrepant insulin results were obtained between an e801 module used at the investigation site and the fujirebio method.It is not known if incorrect results were reported outside of the laboratory.There was no allegation that an adverse event occurred.The e801 module serial number used at the investigation site were (b)(4).

Manufacturer Narrative

Calibration signals from the e801 module were slightly lower than the provided ranges.Qc data was within expectation.The patient sample was not available for further investigation.Product labeling states "samples from patients treated with bovine, porcine or human insulin sometimes contain anti-insulin antibodies.Insulin bound to these antibodies is at least partially recognized by the antibodies used in the elecsys insulin assay." the investigation was unable to find a definitive root cause.

• Brand Name: ELECSYS INSULIN
• Type of Device: IMMUNOREACTIVE INSULIN TEST SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7286084
• MDR Text Key: 100904468
• Report Number: 1823260-2018-00539
• Device Sequence Number: 1
• Product Code: CFP
• Combination Product (y/n): N
• PMA/PMN Number: K001104
• 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: 03/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: 07027559190
• Device Lot Number: 269698
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NOVOLIN 30R