On (b)(6) 2016 the reporter contacted animas alleging that on (b)(6) 2016 the patient was hospitalized for elevated blood glucose (bg) of 611 mg/dl with rapid/deep breathing, abdominal pain, extreme drowsiness, blurred vision, extreme thirst, excess urination, nausea, vomiting, confusion, and large ketones.The patient reportedly remained on the pump and was treated with intravenous fluids, insulin injection(s), and insulin via the pump.The patient reportedly remained hospitalized at the time of contact with animas.The patient's healthcare provider reportedly adjusted basal rates before or after the alleged bg excursion.Customer technical support reviewed the pump with the reporter and found that the basal delivery totals did not match, however the discrepancy was determined to be due to normal pump use, as the suspend feature, basal edit screen, and prime menu had been accessed.Additionally, it was noted that the basal/temp basal rates had been incorrectly programmed and the patient also was experiencing a change in stress level.All other settings and histories were found to be correct.Although no product defects were found during troubleshooting, the patient reportedly insisted the pump be replaced.This complaint is being reported based on the allegation that the patient experienced hyperglycemia requiring medical intervention associated with an alleged pump malfunction.
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Device evaluation: the device has been returned and evaluated by product analysis on 07/05/2016 with the following findings: a review of the pump histories indicated that the pump was manually suspended on 06/09/2016 at 05:32 and manually resumed the same day at 18:07.A review of the total daily dose history indicated that insulin delivery totals correctly reflected programmed values.The pump successfully completed a rewind, load, and prime sequence.The pump was exercised for 24 hours on a 2.0unit per hour basal rate; at the end of the 24 hour testing, the basal history correctly showed 2.0units per hour and the total daily dose history correctly reflected 48.0units.The pump passed delivery accuracy testing and was found to be delivering within required specifications.No delivery interruptions or errors, alarms, or warnings occurred during investigation.Unrelated to the original complaint, investigation revealed that the battery compartment was cracked.Animas has conducted a review of the device history record for this pump and confirmed that it was operating within required specifications at the time of release.(b)(4).
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