Device Problems
Break (1069); Crack (1135)
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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 casing/condition (cracked/damaged casing) issue.It was reported that the cartridge compartment was damaged.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 7/28/2016 with the following findings: during visual inspection of the pump, it was observed that the cartridge compartment was cracked but the test cartridge cap was still able to tighten onto it.The cartridge cap was not returned with the pump and a test cap was used to complete the investigation.Unrelated to the initial complaint, it was observed that the battery compartment had two cracks.
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Search Alerts/Recalls
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