MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723LNAS; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
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Model Number MMT-723LNAS |
Device Problem
Device Difficult to Program or Calibrate (1496)
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Patient Problems
Hyperglycemia (1905); Nausea (1970); Vomiting (2144); Diabetic Ketoacidosis (2364)
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Event Date 10/16/2022 |
Event Type
Injury
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Manufacturer Narrative
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(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.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.Medtronic objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Event Description
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The customer reported via phone call that customer was went to emergency room due to diabetic ketoacidosis and high blood glucose on (b)(6) 2022.The customer¿s blood glucose level was close to 400 mg/dl at the time of the incident.The customer's current blood glucose was 118 mg/dl.The customer reported nausea, vomiting. troubleshooting was performed and the customer indicated that they received no delivery alarms. the customer had been using the insulin pump system within 48 hours of the reported high blood glucose event. there is no information on whether the insulin pump was in auto mode at the time of the incident.No further patient complications were reported.It was unknown whether the customer will continue or discontinue the use of the device.The product will be returned for failure analysis.
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Manufacturer Narrative
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Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.Medtronic objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Information has been added, which was missed in the initial report.The missed information has been provided in section b5, h6 under health effect - clinical code and health effect - impact code with this report.
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Event Description
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Missed description: the customer reported receiving a button error alarm while sleeping.
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Search Alerts/Recalls
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