TANDEM DIABETES CARE T:SLIM X2 INSULIN PUMP; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
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Model Number 1000096 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hyperglycemia (1905); Myocardial Infarction (1969)
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Event Date 06/14/2020 |
Event Type
Injury
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Manufacturer Narrative
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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 was hospitalized on (b)(6) 2020 due to an elevated blood glucose (bg) level (808 mg/dl) caused by the customer incorrectly programming pump settings.Reportedly, the elevated bg level caused the customer to have a heart attack.While in the hospital, the customer was treated with intravenous insulin and fluids.Customer was released from the hospital on (b)(6) 2020 with difficulty walking due to being bedridden while in the hospital.
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