Information received by medtronic indicated that the customer experienced hyperglycemia with a blood glucose value of 600 mg/dl and reported no indications of bolus delivery.The customer reported air bubbles in the reservoir and infusion set.Troubleshooting was performed.It was found that the customer has treated the high blood glucose event with the insulin pump.The customer was using the pump within 48 hours of the reported event.The auto mode/smartguard feature was active.No further patient complications were reported.It was unknown if the customer will continue to use the device.The pump will not be returned for analysis.Frn-mmt-332-rsvr, unomed inf set, ozp-mmt-7020-snsr.
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This mdr related to the puerto rico manufacturing site has been assigned a medwatch number from the medtronic minimed northridge site, per variance 5.Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employees caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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