Device Problem
Structural Problem (2506)
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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.(b)(6).
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Event Description
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On (b)(6) 2018, the reporter contacted animas, alleging that the battery compartment was cracked.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.There was no allegation of an adverse event associated with this complaint.
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Manufacturer Narrative
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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 12-sep-2018 with the following findings:on investigation, the battery compartment was confirmed to be cracked.Investigation duplicated the complaint.
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Search Alerts/Recalls
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