Device Problem
Moisture Damage (1405)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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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.It was reported that there was moisture ingress behind the display.The alleged issue could not be resolved with troubleshooting.There is no indication that the product issue caused or contributed to an adverse event.This complaint is being reported because the alleged malfunction has the ability to result in a delay in treatment or long term cessation in delivery if the damage impacts the power circuit or cartridge compartment.
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Manufacturer Narrative
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The device has been returned and evaluated by product analysis on 8/26/2016 with the following findings: during visual inspection of the pump, it was observed that there was moisture behind the display lens and the pump casing was cracked.A leak test was performed and failed due to the crack in the pump case.The pump was opened and it was observed that there was moisture inside all the internal areas of the pump including on the main printed circuit board (pcb), inside the cover and on the keypad flex connector/transceiver.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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Search Alerts/Recalls
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