Model Number MMT-754CML |
Device Problems
Crack (1135); Moisture Damage (1405)
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Patient Problem
Hyperglycemia (1905)
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Event Date 07/12/2015 |
Event Type
malfunction
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Manufacturer Narrative
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Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned.The device will be returned for analysis and further information will follow once the analysis has been completed.No conclusion can be drawn at this time.The insulin pump involved in this event is the paradigm real-time veo insulin infusion pump, which is not marketed in the united states.However, the device is similar to the paradigm real-time insulin infusion pump, which is marketed in the united states.
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Event Description
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It was reported that the customer's insulin pump was exposed to moisture.It was also reported that the insulin pump has a crack.Customer's blood glucose level at the time 9.0 mmol/l.Troubleshooting occured.Advised insulin pump would be replaced.
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Manufacturer Narrative
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The insulin pump was received with no moisture damage to the electronic assembly.However, the insulin pump has minor scratched lcd window, cracked case near the display window corners, cracked reservoir tube lip and missing the end cap sticker.
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Search Alerts/Recalls
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