The customer was reported via phone call that, the customer was hospitalised on (b)(6) 2020 for low blood glucose of 26 mg/dl.The low blood glucose was treated with glucose and iv.The drive support cap appears normal.Based on customer report, customer does not allege over-delivery of insulin.The customer was found unresponsive in vehicle.The insulin pump will be returned for analysis.
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Device passed the functional test, including the displacement test, rewind, basic occlusion test, occlusion test, prime or a33 test, excessive no delivery test and delivery accuracy test at 0.08755 inches.No over delivery anomaly or under delivery anomaly noted.The stop (idle) current and run current measurement tests are within specification.Device also passed self test, off no power alarm test and a21 error test.Device uploaded properly using carelink.Device had cracked display window, cracked case at display window corner, cracked battery tube threads, scratched reservoir tube window, cracked reservoir tube lip, stained end cap sticker and scratched case.The test p-cap and reservoir does lock in place in the reservoir compartment.(b)(4).
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