Model Number MMT-754CML |
Device Problem
Device Displays Incorrect Message (2591)
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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 received a compromised force sensor system alarm customer's blood glucose level at the time 17.1 mmol/l.Troubleshooting occurred.Advised to discontinue use of the insulin pump, and revert to a back-up plan.The customer was advised that the device would be replaced and agreed to return the product for analysis.
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Manufacturer Narrative
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The insulin pump alarmed a33 during the basic occlusion test due to loose protruded drive support disk.The insulin pump was received with broken battery tube thread, broken belt clip slot, cracked reservoir tube lip and missing the end cap sticker noted.
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Search Alerts/Recalls
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