Model Number MMT-751NAH |
Device Problems
Failure to Prime (1492); Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/09/2018 |
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.The device has been returned, but not yet evaluated.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 the insulin pump had prime rewind anomaly.The customer¿s blood glucose level was unknown at the time of the incident.The customer stated that they are unable to exit the preparing to prime loop.The customer stated that the drive support cap was flush.The customer was advised that the insulin pump needed to be replaced and was advised to discontinue use of the insulin pump and to revert to the backup plan.The insulin pump will be returned for analysis.
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Manufacturer Narrative
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Insulin pump passed the displacement test but received compromised force sensor system alarm during the basic occlusion test due to loose/protruded drive support disk.Unable to perform the occlusion, prime/compromised force sensor system and excessive no delivery test or verify prime/fill anoamly due to compromised force sensor system alarm.
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Search Alerts/Recalls
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