Device Problem
Device Stops Intermittently (1599)
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Patient Problems
Fatigue (1849); Hyperglycemia (1905); Nausea (1970); Urinary Frequency (2275); Polydipsia (2604)
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Event Date 06/01/2016 |
Event Type
Injury
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Manufacturer Narrative
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The pump has not been returned to animas.If the device is returned, an evaluation shall be completed and a supplemental report will be filed.No conclusions can be made at this time.
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Event Description
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On 06/03/2016 the reporter contacted animas alleging that on (b)(6) 2016 the patient was hospitalized for elevated blood glucose (bg) of 399mg/dl with nausea, extreme drowsiness, extreme thirst, and excess urination associated with an intermittent power issue.The patient reportedly discontinued insulin pump therapy and was treated with insulin via injection, intravenous glucose, and other unspecified treatment.There was reportedly no moisture/corrosion in the battery compartment and the battery cap¿s yellow o-ring was not visible at the time of the alleged power issue.The reporter noted that the battery compartment was damage.This complaint is being reported based on the allegation that the patient experienced hyperglycemia associated with an intermittent power issue.
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Manufacturer Narrative
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Follow-up #1 date of submission 06/30/2016: correction to incident description.Animas has conducted a review of the device history record for this pump and confirmed that it was operating within required specifications at the time of release.
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Event Description
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On (b)(6) 2016 the reporter contacted animas alleging that on (b)(6) 2016 the patient was hospitalized for elevated blood glucose (bg) of 399mg/dl with nausea, extreme drowsiness, extreme thirst, and excess urination associated with an intermittent power issue.The patient reportedly discontinued insulin pump therapy and was treated with insulin via injection and other unspecified treatment.There was reportedly no moisture/corrosion in the battery compartment and the battery cap's yellow o-ring was not visible at the time of the alleged power issue.The reporter noted that the battery compartment was damaged.This complaint is being reported based on the allegation that the patient experienced hyperglycemia associated with an intermittent power issue.
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Search Alerts/Recalls
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