Field Safety Notice - Accuchek Insight Adapter And Tubing

[everydayupsanddowns]

I suspect anyone that this applies to has already been contacted... but I have just been alerted to this voluntary recall by Roche

Roche Diabetes Care are conducting a voluntary recall related to previous design-versions of the Accu-Chek Insight insulin pump adapter and tubing.​

As part of our ongoing quality monitoring and market surveillance processes, we have identified that insulin leakage can occur in a low number of cases with the Accu-Chek Insight adapter and tubing consumable which connects the pre-filled insulin cartridge with the insulin pump.​

We conducted an in-depth evaluation of the issue and implemented the appropriate corrective measures by means of technical enhancements to the adapter needle in the Accu-Chek Insight adapter and tubing consumable to reduce the incidence of leakage.​

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All patients and healthcare professionals who may have affected stock are being contacted and replacements of all in-date affected stock are being issued​

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[Amity Island]

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a national patient safety alert for the NovoRapid PumpCart prefilled insulin cartridge and the Roche Accu-Chek Insight Insulin pump system following concerns raised about cracked cartridges and insulin leaks.

New safety warnings on risk of insulin leakage from Roche Accu-Chek Insight Insulin pumps

The UK regulator has taken safety action to reduce risks associated with Roche Accu-Chek Insight Insulin Pumps by issuing a national safety alert and outlining recommendations for patients.

www.gov.uk

 

[everydayupsanddowns]

Diabetes UK has now posted a page on their website concerning this.

Safety warnings on risk of insulin leakage from Roche Accu-Chek Insight Insulin pumps

National Patient Safety Alerts are issued to make sure action is taken by healthcare providers to keep patients safe. This has happened because the MHRA is concerned that these products may contain cracked cartridges, which could result in leaking insulin. This would mean that people using their...

www.diabetes.org.uk