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Model Number 14000 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Nausea (1970); Pneumonia (2011); Virus (2136); Respiratory Tract Infection (2420)
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Event Date 07/01/2019 |
Event Type
Injury
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Manufacturer Narrative
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The device was not returned for evaluation.We are unable to determine if any product condition could have contributed to the reported elevated blood glucose levels.No lot release records were reviewed, as the product lot number was not provided.Omnipod insulin management system ¿ user guide.Model: ust400.17845-5a-aw rev b 09/17.Checking your blood glucose.Chapter 4 / page 36.Warnings: test results below 70 mg/dl mean low blood glucose (hypoglycemia).Test results greater than 250 mg/dl mean high blood glucose (hyperglycemia).If you get results below 70 mg/dl or above 250 mg/dl, but do not have symptoms of hypoglycemia or hyperglycemia (see "living with diabetes" on page 115), repeat the test.If you have symptoms or continue to get results that fall below 70 mg/dl or above 250 mg/dl, follow the treatment advice of your healthcare provider.
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Event Description
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It was reported that the patient had been having problems keeping his bg (blood glucose) levels down.He had been treating his high bg by attempting to bolus through the pod, but he wound up bolusing through manual injections.He followed up with his doctor after an er visit two days prior, where was diagnosed with a virus/upper respiratory infection, and was diagnosed with pneumonia and prescribed an antibiotic.He had previously been given antibiotics, inhalers and anti-nausea medication, he was advised to take over the counter pain relievers (tylenol/motrin).Patient had respiratory distress and shortness of breath.
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Search Alerts/Recalls
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