Model Number 4628-003 |
Device Problems
Difficult to Insert (1316); Material Deformation (2976)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 04/18/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The device is expected to be returned; however, the device has not yet been received.A supplemental report will be submitted if the device is received.Device not returned.
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Event Description
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It was reported that multiple cartridges did not fit onto the pump.Pump damage was observed on the pump resulting in the cartridge fit issue.Customer's blood glucose level was 134 mg/dl.Reportedly, the customer continued to use the pump for insulin therapy.
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Manufacturer Narrative
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The investigation has been completed.Based on the analysis, the alleged malfunction was verified and a different issue was identified.
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Search Alerts/Recalls
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