Medtronic warns patients of MiniMed insulin pump safety issue

美敦力召回有安全漏洞的胰岛素泵

2019-11-25 11:07:34 Mass Device

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Medtronic is warning patients who use its MiniMed 600 series insulin pumps of an issue that could cause a dangerous over- or under-dosing of insulin. In a letter to patients, the company said that the pump’s insulin reservoir may become loose if a retainer ring breaks, preventing a proper lock. Dropping the pump or bumping it on a hard surface may break that ring, the company said. 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. The recall covers MiniMed 630G  (model MMT-1715) and MiniMed 670G (model MMT-1780). A company spokesperson told the StarTribune of Minneapolis that Medtronic had received one report of a patient being hospitalized due to a retainer-ring issue, and one report of a death which may have been associated with the issue. Medtronic advised patients to stop using the device if  the reservoir does not lock into the pump or if the is loose, damaged or missing. The company also said patients who drop or bump their pumps should examine the retainer ring and check that the reservoir locks properly. All patients should routinely check the retainer ring and check that your reservoir locks in place at every set change, the company added. The company also said it had notified the FDA of the issue. Medtronic did not immediately respond to a request for comment on the recall. Medtronic’s MiniMed 670G system is designed to automatically track and adjust a patient’s blood sugar levels by measuring blood glucose every few minutes and automating the dosing of insulin. The automated insulin delivery system first won FDA approval in September 2016. The FDA approved the MiniMed 630G in 2017.
美美敦力(Medtronic)公司警告使用其 MiniMed 600系列胰岛素泵的患者可能会导致危险的胰岛素过量或不足。 该公司在一封致患者的信中表示,如果固定环断裂,泵的胰岛素贮存器可能会变得松散,从而防止出现合适的锁。该公司表示,在坚硬的表面上滴下泵或撞上泵可能会破坏环。如果油藏没有正确地锁定在泵中,它可能导致胰岛素的过量或不足,从而导致低血糖或高血糖。召回范围包括 MiniMed630G (型号 MMT-1715)和 MiniMed670G (型号 MMT-1780)。 一位公司发言人对明尼阿波利斯的 StarTribune 说,美敦力(Medtronic)公司收到了一份报告,称一名病人因停留期问题住院,还有一份死亡报告可能与该问题有关。 美美敦力(Medtronic)建议患者停止使用该设备,如果水库没有锁定到泵,或如果是松散,损坏或失踪。该公司还说,病人谁下降或颠簸他们的泵应该检查固定环和检查水库锁适当。该公司补充说,所有患者都应定期检查固定环,并在每次更换时检查油层锁是否到位。 该公司还表示,已将此事通知 FDA 。美美敦力(Medtronic)没有立即回应对召回事件发表评论的请求。 美敦力(Medtronic)的 MiniMed 670G 系统旨在通过每隔几分钟测量血糖并实现胰岛素剂量的自动化,自动跟踪和调整患者的血糖水平。自动化胰岛素输送系统于2016年9月首次获得 FDA 批准。FDA 在2017年批准了 MiniMed630G 。

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