(b)(4).Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned.The device will be returned for analysis and further information will follow once the analysis has been completed.No conclusion can be drawn at this time.The insulin pump involved in this event is the paradigm real-time 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.
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Insulin pump passed the functional test, including the self test, sleep current measurement, active current measurement, rewind test, prime/seating test, basic occlusion test, occlusion test, force sensor test, displacement test and the dat test at 0.08720 inches.Insulin pump passed tone check and vibrate check on self test.No audio/beep anomaly or vibrate anomaly noted during testing.Insulin pump powered up properly when the test battery was installed.Insulin pump was monitored for 1 day.No blank display noted.The power management tool confirmed the unloaded voltage (ul vlith) and loaded voltage (loaded vlith) was within spec range.No power error detected, low battery alert, power loss alarm, replace battery alert or replace battery now alarm noted during testing.Unit uploaded properly using carelink.Pump trace download confirmed hardware low level failures (variable 3) due to broken trace at pin 6 (sda) on keypad assembly.Toggled on/off and increased/decreased volume with the audio feature functioning properly.No audio/vibrate/absence of alarm anomalies noted during testing.Insulin pump had scratched case and a pillowing keypad overlay.
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