Device Problem
Defective Alarm (1014)
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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.
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Event Description
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On (b)(6) 2019, the reporter contacted animas, alleging a audio tone/vibration (vibration issue) issue.There was no indication that the product caused or contributed to an adverse event.This complaint is being reported because the issue may cause the user to miss an alarm or warning that may cause cessation of insulin delivery.
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Manufacturer Narrative
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Device evaluation: the device has been returned and evaluated by product analysis on 23-aug-2019 with the following findings: during testing, the pump was powered on and the vibration functioned normally.The complaint of a vibration issue was not duplicated during 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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