Model Number MMT-1715KL |
Device Problem
Insufficient Flow or Under Infusion (2182)
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Patient Problems
Fatigue (1849); Hyperglycemia (1905); Polydipsia (2604)
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Event Date 12/24/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.
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Event Description
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Information received by medtronic indicated that the insulin pump under delivering because the customer¿s blood glucose did not come down.Customer's blood glucose value was 300 mg/dl at the time of the incident.The customer was assisted with troubleshooting for high blood glucose.The customer stated that the symptoms related to high blood glucose such as extreme thirst, sort of malaise and overall bad feeling.The customer was treated with manual injection and insulin.Customer had been using insulin pump system within 48 hours of reported high blood glucose event.It was unknown that auto mode feature was active or not at the time of event.No harm requiring medical intervention was reported.The device will not be returned for analysis.
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Manufacturer Narrative
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(b)(4).Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.
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Event Description
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Information received by medtronic indicated that the insulin pump under delivering because the customer¿s blood glucose did not come down.Customer's blood glucose value was 300 mg/dl at the time of the incident.The customer was assisted with troubleshooting for high blood glucose.The customer stated that the symptoms related to high blood glucose such as extreme thirst, sort of malaise and overall bad feeling.The customer was treated with manual injection and insulin.Customer had been using insulin pump system within 48 hours of reported high blood glucose event.It was unknown that auto mode feature was active or not at the time of event.No harm requiring medical intervention was reported.The device will not be returned for analysis.
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Search Alerts/Recalls
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