Device Problem
Sticking (1597)
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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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Calibra has been unable to request return of the product at this time.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, it was reported that on the first dose, the buttons were " sticky" and then stayed in the locked position.The patient was said to have replaced the patch with a new one, and dose was delivered without issue.There was no indication that the product caused or contributed to an adverse event.This complaint is being reported because the device was unable to deliver insulin.
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Manufacturer Narrative
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Follow-up #1 04/06/2016 device evaluation: the inserter has been returned and evaluated by product analysis on (b)(6) 2016 with the following findings: the patch showed evidence that the device was filled, partially debubbled and deployed.The patch buttons were not locked per the allegation upon receipt of the product.During testing the device was clicked several times without issues.The button travel was not found to be hindered or sticking during testing.There was no foreign material noted on the patch and there was no damage to the buttons, casing, or any of the springs.The cannula appeared slightly bent during investigation however this appeared to be related to lack of protection during shipping.The alleged sticking button allegation was unable to be confirmed or duplicated during testing.
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Search Alerts/Recalls
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