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Model Number 18320 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Hyperglycemia (1905); Nausea (1970); Diabetic Ketoacidosis (2364); No Code Available (3191)
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Event Date 07/14/2020 |
Event Type
Injury
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Manufacturer Narrative
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According to the complainant the device is not being returned for investigation.We are unable to determine if any product condition could have contributed to the reported er visit, diabetic ketoacidosis, glucosuria and hyperglycemia.No lot release records were reviewed, as the product lot number was not provided., for your reference, insulet modified our internal investigation finding codes effective 25 may 2020 as part of an effort to improve the classification of findings to improve the power of trending data and make the findings more intuitive.The new findings codes will use the system of finding category (e.G.Hardware component), followed by the affected component (e.G.Needle), followed by the condition (e.G.Bent).Therefore you may notice findings that appear to be new or different but in fact are just renamed for improved data value.Insulet would be happy to explain any mapping of the old to new finding codes if you have any questions.
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Event Description
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It was reported that a patient went to the emergency room (er) and was diagnosed with diabetic ketoacidosis (dka) with glucosuria.The patient's blood glucose (bg) values reached 280 mg/dl.For treatment, patient was given saline through intravenous (iv), random bg test, covid-19 test, (ua) complete urinalysis, ecg (electrocardiogram), chest x-ray, and blood work including cbc with auto differential, basic metabolic panel, blood gases venous, and beta hydroxybutyrate.The patient was prescribed ondansetron (zofran) 4 mg tablet, to take one tablet by mouth every 8 hours as needed for nausea.The pod was removed after wearing longer than 48 hours on the leg and discarded.
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Search Alerts/Recalls
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