Product Recalls and Safety Information
If there are any diabetes product recalls or safety notices that could affect our patient population, it will be posted below along with any relevant links for further information. Be sure to sign up for our newsletter to receive any safety alerts from our Pediatric Diabetes Team.
Glucagon Emergency Kit Recall
Eli Lilly and Company is voluntarily recalling lot D239382D, Expiration April 2022, of Glucagon Emergency Kit for Low Blood Sugar (Glucagon for Injection, 1 mg per vial; Diluent for Glucagon, 1 mL syringe).
Lilly is recalling lot D239382D because of a product complaint reporting that the vial of Glucagon was in liquid form instead of the powder form. The firm’s investigation indicates that the liquid in this Glucagon vial could be related to the manufacturing process. The use of the liquid form of this product may fail to treat severe low blood sugar due to loss of potency.
The product is packaged in a kit containing 1mg of freeze-dried product in a 3mL vial and a pre-filled syringe. The affected Glucagon Emergency Kit lot is D239382D and the expiration date is April 2022 (label expiry date: 04 2022). The lot number can be found on the label of the kit as well as the vial.
See the FDA announcement for photos of the recalled kit and where to find the lot number and expiration date.
Medtronic MiniMed 630G and 670G Retainer Ring Issues
This recall affects MiniMed™ 600 series insulin pumps with a clear retainer ring. Medtronic first communicated about this recall in November 2019 with instructions to examine your pump for potential retainer ring damage and instructions to contact us if the retainer ring appeared to be loose, damaged, or missing.
Medtronic is updating this recall to replace any MiniMed™ 600 series insulin pump that has a clear retainer ring with a MiniMed™ 600 series insulin pump that has the updated black retainer ring design. Insulin pumps with the updated black retainer ring design are not impacted by this recall. There is no charge for the replacement, and it will be provided even if the clear retainer ring is not damaged and regardless of the warranty status of the pump.
The MiniMed™ 600 series insulin pump is designed with a pump retainer ring to lock the reservoir in the insulin pump. There have been reported incidents of a loose reservoir that can no longer be locked into the pump. The reservoir can become loose due to a broken or missing retainer ring that prevents a proper lock. The retainer ring can be broken, for example, as a result of dropping or bumping your pump on a hard surface.
If the reservoir is not properly locked into the pump, it could lead to over or under delivery of insulin, which could then result in hypoglycemia or hyperglycemia. For example, if the pump retainer ring is broken or becomes detached from the pump, and the user inserts the reservoir back into the pump while the infusion set is still connected to the body, it could result in a rapid infusion of insulin, which could cause hypoglycemia. The under delivery of insulin could occur if the reservoir is not properly locked in place by the retainer ring, creating a space between the pump and the reservoir, and prevent the pump from pushing the expected insulin into the body, which could cause hyperglycemia.
This issue may affect users of the MiniMed™ 630G and 670G insulin pumps. The pump model number can be found directly on the bottom or on the back of the device.
MiniMed™ 630G insulin pump: MMT-1714, MMT-1715, MMT-1754, MMT-1755
MiniMed™ 670G insulin pump: MMT-1580, MMT-1741, MMT-1742, MMT-1760, MMT-1761, MMT-1762, MMT-1780, MMT-1781, MMT-1782
Please visit www.medtronicdiabetes.com/PumpRing and complete the form online or call us at 1-877-585-0166 to indicate your decision to receive a replacement pump at no charge. Replacement pumps will become available in the coming months, and you will be notified when your pump is ready to ship. Replacement pumps will continue to be immediately available if you experience an issue with the retainer ring on your current pump.
Visit www.medtronicdiabetes.com/PumpRing for more information.