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Model Number 14000 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Hyperglycemia (1905); Unspecified Infection (1930)
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Event Date 05/17/2016 |
Event Type
Injury
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Manufacturer Narrative
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The product was not returned for evaluation.We are unable to determine if any product malfunction or other product condition could have contributed to the reported hyperglycemia and hospitalization.No product lot number was reported therefore no lot release records were reviewed.The omnipod¿s user guide warns "test results greater than 250 mg/dl mean high blood glucose (hyperglycemia).If you get results above 250 mg/dl, but do not have symptoms of hyperglycemia, repeat the test.If you have symptoms or continue to get results above 250 mg/dl, follow the treatment advice of your healthcare provider.
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Event Description
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The patient's mother reported that her daughter had to be hospitalized due to high blood glucose levels.At the hospital she was diagnosed with an enlarged kidney, heartbeat of 183, blood infection, kidney infection, and had a stent placed in her kidney.She did not provide any further information regarding the hospitalization.
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Search Alerts/Recalls
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