A 66-year-old man with insulin-dependent diabetes mellitus and severe hypoglycaemia unawareness died on 20 June 2013, the day after commencing a Medtronic Paradigm insulin pump. He was found collapsed at home after planning to change his insulin pump vial. Cause of death was unascertained. Clinical lessons include: a dietician formal assessment should have been undertaken during pump initiation, not deferred to family members, given his inaccurate carbohydrate counting; pump data from 17-20 June 2013 was corrupted preventing analysis of potential overdose; his history of severe hypoglycaemia with poor symptom recognition may have contributed; multiple Medtronic safety advisories before his death included risks of unintended insulin bolus delivery. The commencement of quick-acting insulin infusion via pump was a significant change from his prior slow-acting regimen.
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insulin pump insertion and commencementcarbohydrate counting assessment
Contributing factors
possible hypoglycaemia from insulin pump malfunction or operator error
history of severe hypoglycaemia with poor symptom awareness
transition to new insulin pump technology with quick-acting insulin
mild cognitive impairment
inaccurate carbohydrate counting skill
possible drive support cap failure of Paradigm pump allowing unintended insulin bolus
loss of historical pump data preventing investigation of events 17-20 June 2013
Coroner's recommendations
Warringal Private Hospital should implement more thorough screening, possibly through dietician assessment, for all patients admitted for insulin pump commencement, to ensure adequate carbohydrate counting and insulin calculating ability
Medtronic Australia Pty Ltd should install additional data retention technology to Paradigm insulin pump or implement a policy to salvage historical pump data as a matter of priority when devices are under review, to prevent data corruption
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