The customer reported via phone call that they experienced high as well as blood glucose.Customer¿s blood glucose was 572 mg/dl,499 mg/dl,47 mg/dl.The customer was treated with needle.Troubleshooting was done for high blood glucose and under delivery.The customer was neither in the emergency room, nor admitted into hospital as a result of high blood glucose.Based on customer report customer did not allege insulin pump was under delivering.Customer was spotted a little bit of blood at the site.Customer also reported that insulin pump received insulin flow block alarm but displacement test was passed ans also received software error.The insulin pump will be returned for analysis.
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Device passed the displacement test, rewind test, prime/seating test, basic occlusion test, force sensor test, occlusion test, self test and displacement accuracy test.No delivery alarm/occlusion - unknown timing not confirmed.The motor was tested outside of the pump and passed.No unexpected pump error 53 alarms noted during testing however, the formatted history file confirmed pump error 53 alarm.Problem isolated to electronic assembly.
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