Device Problems
Moisture Damage (1405); Inaccurate Delivery (2339)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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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.(b)(6).
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Event Description
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On (b)(6) 2016, the reporter contacted animas, alleging a power (damage with moisture ingress) issue.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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Manufacturer Narrative
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Follow-up #1: date of submission 09/19/2016.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.Device evaluation: the device has been returned and evaluated by product analysis on 08/26/2016 with the following findings: review of the black box data revealed records of unexplained power on reset.On examination, the battery compartment was cracked as well as the pump case.Investigation confirmed the alleged damage.There was moisture corrosion inside the battery compartment.Investigation confirmed the alleged moisture ingress.The pump was exercised for 24 hours using the undamaged returned battery cap.Power on reset was not duplicated during the exercise.Leak testing confirmed moisture leakage at the damaged battery compartment and pump case.The pump was opened for further investigation and reveal moisture damage inside the pump on the printed circuit board and other internal components; no damage of the power circuit was found.
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Search Alerts/Recalls
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