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Model Number 14000 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Dehydration (1807); Hyperglycemia (1905); Nausea (1970); Virus (2136); Vomiting (2144); Diabetic Ketoacidosis (2364)
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Event Date 06/16/2020 |
Event Type
malfunction
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Manufacturer Narrative
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According to the complainant the device will not be returned for investigation.We are unable to determine if any product condition could have contributed to the reported hospitalization and diabetic ketoacidosis.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 the patient had been hospitalized with diabetic ketoacidosis (dka).The patient's blood glucose levels rose from 328 mg/dl to 366 mg/dl while wearing the pod longer than 48 hours.Symptoms reported include hyperglycemia, nausea, vomiting and dehydration; high ketones were also present.Patient was admitted to the intensive care unit (icu) the pod was removed and patient was treated with an insulin drip, potassium, magnesium and zofran for vomiting; she was also prescribed zofran (4 mg) for an unknown period of time.The patient was released after spending 2 days in the hospital.Patient also reported having a stomach virus.
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Search Alerts/Recalls
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