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

Model Number INSULIN

Device Problem Low Test Results (2458)

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

Event Type  malfunction  

Manufacturer Narrative

The investigation results are not yet available.The follow up/corrective actions are not yet available.No devices were returned.This device is not labeled for single use and is not reprocessed or reused.

Event Description

This report summarizes 1 malfunction event.Low results were generated by the cobas 8000 e 602 module.The event involved 1 patient with low results for elecsys insulin.The patient's age was requested, but was not provided.The patient's weight was requested, but was not provided.The patient's gender was requested, but was not provided.The patient's race was requested, but was not provided.The patient's ethnicity was requested, but was not provided.

Manufacturer Narrative

The patient sample was provided for further investigation.The investigation determined that the high insulin results were consistent with anti-insulin autoantibodies being present in the patient sample.An interference with igg in the sample was likely the root cause.Per product labeling "samples from patients treated with bovine, porcine or human insulin sometimes contain anti-insulin antibodies which can affect the test results.In rare cases, interference due to extremely high titers of antibodies to analyte-specific antibodies, streptavidin or ruthenium can occur.These effects are minimized by suitable test design.For diagnostic purposes, the results should always be assessed in conjunction with the patient's medical history, clinical examination and other findings".

• Brand Name: ELECSYS INSULIN
• Type of Device: IMMUNOREACTIVE INSULIN TEST SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• MDR Report Key: 8280769
• MDR Text Key: 134351956
• Report Number: 1823260-2019-90040
• Device Sequence Number: 1
• Product Code: CFP
• UDI-Device Identifier: 04015630913060
• UDI-Public: 04015630913060
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: INSULIN
• Device Lot Number: ASKU
• Patient Sequence Number: 1