Notification to inform customers of a potential issue relating to pump's battery cap and provide actions required by the customers. Notification advises customers that if the metal contact becomes loose or falls off from the battery cap, this can result in an incomplete battery connection, leading to a loss of power source to the pump. When the pump detects no power source, an "insert battery" alarm will occur, and insulin delivery will immediately stop. After 10 minutes, the alarm sound may increase to a siren, and the pump will turn off. If the pump stops delivery of insulin due to power loss, this could lead to varying degrees of high blood sugar, including diabetic ketoacidosis (dka). Serious injuries have been reported with the use insulin pumps associated with the damaged cap, but not all have been directly correlated to this issue based on review with independent clinical experts. Damaged battery cap contacts could potentially lead to those events as explained above. Recall start date: June 2, 2022
RecallTracker