Device Problems
Moisture Damage (1405); High Test Results (2457)
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Patient Problem
Hyperglycemia (1905)
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Event Type
Injury
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Manufacturer Narrative
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The pump has not been returned to animas for evaluation.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 (b)(6) 2016, the reporter contacted animas, alleging a casing/condition (moisture ingress) issue.The reporter stated that the patient had a blood glucose (bg) of 29mmol/l with headache and extreme drowsiness.The patient did not receive any treatment above and beyond the usual routine care of diabetes management.Customer support (cs) completed troubleshooting and there was moisture ingress behind display.This report is being made due to the bg excursion the patient experienced due to an alleged casing/condition issue.
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Manufacturer Narrative
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Follow-up #1: date of submission 09/06/2016 device evaluation: the device has been returned and evaluated by product analysis on 08/11/2016 with the following findings: the pump was returned with moisture behind display lens.Battery compartment is cracked on the side from threads to cover.Base crack observed between case seal and keypad.The black box shows a replace cartridge alarm on (b)(6) 2016 at 17:27, followed by occlusion alarms at 20:36 and 20:50.The pump was manually suspended on (b)(6) 2016 13:13 and manually resumed at 13:53.The daily insulin delivery totals correctly reflect user's programmed basal rates.The pump passed delivery accuracy test and was found to be delivering within required range and delivering accurately.A leak test fails due to battery compartment crack and base crack.Removed pump cover; internal moisture was confirmed on the pcb and internal components.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.(b)(4).
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Search Alerts/Recalls
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