On (b)(6) 2016, the reporter contacted animas, alleging the subject pump had intermittent power.The reporter also claimed that the battery compartment was cracked and contained moisture.This complaint is being reported because the user may be unaware that the pump has lost power, leading to under delivery.There was no indication that the product caused or contributed to an adverse event.
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Follow-up #1: date of submission 10/04/2016.Device evaluation: the device has been returned and evaluated by product analysis on 09/07/2016 with the following findings: a review of the pump¿s black box revealed consecutive cs 087 and 52 alarms.There was moisture observed in the battery compartment and under the display lens.The battery compartment was found to be cracked.A leak test failed due to a battery compartment leak.The keypad was undamaged and the keypad cover was opened and there was no contaminants found under contacts.The pump was opened and there was moisture damage found on the display, keypad flex, connector and other components.The battery cap was tightened and then fully loosened on half turn and the power to pump was not interrupted.
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