TANDEM DIABETES CARE T:SLIM X2 INSULIN PUMP; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
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Model Number 1002717 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hypoglycemia (1912); Pneumonia (2011); Swelling (2091)
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Event Date 07/12/2019 |
Event Type
Injury
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Manufacturer Narrative
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The t:slim x2 ous pump user guide states "only your healthcare provider can determine and help you adjust your basal rate(s), carb ratio(s), correction factor(s), target bg, and duration of insulin action.In addition, only your healthcare provider can determine your cgm settings and how you should use your sensor trend information to help you manage your diabetes.Incorrect settings can result in over delivery or under delivery of insulin.This can cause very low or very high blood glucose." no product was returned for evaluation.Should new relevant information become available, a supplemental report will be submitted.
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Event Description
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It was reported that the customer experienced a blood glucose (bg) level of 32 mg/dl and became unconscious.Reportedly, the customer was transferred to the hospital via ambulance.Reportedly, the customer experienced "body swelling" and aspiration pneumonia that required the customer to be transferred to a regional hospital for further monitoring on (b)(6) 2019.The customer had reportedly changed basal rates repeatedly without consulting the healthcare provider.Reportedly, the customer consulted the healthcare provider for additional training.No additional information was provided.
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