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 battery 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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Follow-up # 1; date of submission: 9/20/2016.The device has been returned and evaluated by product analysis on 8/27/2016 with the following findings.During visual inspection of the pump, it was observed that the battery compartment had two cracks.Unrelated to the initial complaint, it was observed that the pump casing was cracked between the case seal and the keypad cover and was also cracked between the case seal and the display lens corner.The battery cap was not returned with the pump and a test cap was used to complete the investigation.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.
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Search Alerts/Recalls
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