Model Number MMT-551NAS |
Device Problems
Excess Flow or Over-Infusion (1311); Self-Activation or Keying (1557)
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Patient Problems
Hyperglycemia (1905); Hypoglycemia (1912); Overdose (1988); Loss of consciousness (2418)
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Event Date 07/12/2015 |
Event Type
Injury
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Event Description
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The customer reported via phone call that paramedics were recently called in response to a blood glucose level of 21 mg/dl.The customer reported the she went to bed with a blood glucose level of 330 mg/dl, then lost consciousness.Customer's husband called paramedics when he found her unresponsive.The customer stated that she was treated by paramedics, but not transported to a hospital.The customer stated that review of her bolus history showed that she received two unintentional boluses.The customer began troubleshooting, but declined to complete.Blood glucose level at the time of the call was 262 mg/dl.The customer was advised that the insulin pump would be replaced and agreed to return the device for analysis.
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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.This mdr related to the puerto rico manufacturing site has been assigned a medwatch number from the medtronic minimed northridge site, per variance 5.
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Manufacturer Narrative
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The insulin pump passed the prime test, displacement test, rewind, basic occlusion test, occlusion test and excessive no delivery alarm tests.The insulin pump was tested with a test transmitter and glucose sensor simulator and was programmed with multiple glucose values.All registered properly in the update history.The insulin pump was monitored for several days and no unexpected bolus delivery was noted.No cosmetic damage was noted.
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Search Alerts/Recalls
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