(b)(4).The insulin pump involved in this event is the 640g insulin infusion pump, which is not marketed in the united states.However, the device is similar to the paradigm real-time insulin infusion pump, which is marketed in the united states.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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The customer reported via phone call that they experienced high blood glucose and sepsis, which resulted in a hospitalization.The customer's blood glucose level at the time of incident was 600 mg/dl.Customer also stated that insulin pump had blank display after being exposed to the moisture, but display returned after pump restart.Customer stated that self test passed.The insulin pump will not be returned for analysis.
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