Customer called and reported that they received emergency medical assistance due to low blood glucose on (b)(6) 2018 with blood glucose of 35 mg/dl at the time of the incident.The customer was at 117 mg/dl at the time of the call.The customer used glucose tablets to treat.The customer experienced symptoms such as seizures.The customer was wearing the insulin pump during the incident.The customer gets random lows and believes the pump may be over delivering.Troubleshooting was completed for the lows, but not completed for the highs as the customer declined.The customer also experiences highs of up to 400 mg/dl due to hardened tissue, and had a low of 50 mg/dl in 2017.The insulin pump will be returned for analysis.
|
Pump passed all functional tests, including the idle current measurement test, run current measurement test, self test, off no power test, unexpected restart error test, displacement test, basic occlusion test, occlusion test, prime test, rewind test, excessive no delivery test and delivery accuracy test.
|