Device evaluation: the device has been returned and evaluated by product analysis on 06/29/2017 with the following findings: a review of the black box showed the data from the date of the complaint had been overwritten.The current black box showed evidence of an unexplained power on reset event.The pump intermittently powered on with the returned battery cap.The battery cap threads were damaged and the battery cap measured within specifications.A test battery cap was used for all testing.The battery compartment was cracked from the thread area to the case seal.The battery compartment threads were damaged.Evidence of moisture was found inside the battery compartment, and on the underside of the battery cap.The rewind, load, and prime steps were performed successfully.The pump was run for 24 hours and no reboots, loss of powers or call service alarms were duplicated.The pump case was removed to find no evidence of additional moisture.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.
|