Model Number MMT-1715KL |
Device Problems
Insufficient Flow or Under Infusion (2182); No Apparent Adverse Event (3189)
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Patient Problems
Hyperglycemia (1905); Urinary Frequency (2275); Polydipsia (2604)
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Event Date 06/13/2020 |
Event Type
Injury
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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.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.
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Event Description
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The customer reported via phone call that they were experiencing high blood glucose.Blood glucose level at the time of the incident was 581 mg/dl.Customer stated that her blood glucose has been high all day.Customer stated she changed her set and they remained high.Customer tested to make sure her insulin was being delivered, but none came off.Customer stated they experienced thirst with frequent urination.Customer has been using insulin pump system within 48 hours of reported high blood glucose event.Customer treated for high blood glucose with injection.Customer does not alleged insulin pump was under delivering.Customer declined to check their settings.Customer did a 5 units fill cannula and stated no insulin came out of the insulin pump.Customer did not use a sensor.The insulin pump will be and reservoir will not be returned for analysis.
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Manufacturer Narrative
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Device passed the full functional test including the displacement test, rewind, prime or seating test, basic occlusion test and force sensor test.Sleep current measurement and active current measurement within specifications.No unexpected insulin flow blocked alarm noted during testing.Device passed the delivery accuracy test at 0.08760 inches.Device was uploaded using carelink pro.Carelink pro listed all test data.No history anomaly noted on carelink pro.(b)(4).
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Search Alerts/Recalls
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