MEDTRONIC PUERTO RICO OPERATIONS CO. PUMP MMT-1712KL 640G V4.10 BK SF MG; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
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Model Number MMT-1712KL |
Device Problem
Excess Flow or Over-Infusion (1311)
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Patient Problems
Hypoglycemia (1912); Loss of consciousness (2418)
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Event Date 11/19/2023 |
Event Type
Injury
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Event Description
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Information received by medtronic indicated that the customer reported that the pump was over delivery and reported that when the pump was suspended it delivered insulin.Troubleshooting was performed.The customer also reported low blood glucose of 31mg/dl at the time of the incident.The customer used the insulin pump system within 48 hours of the reported low blood glucose event, and the auto mode feature was not active at the time of the event.No further patient complications were reported.The customer continued using the pump and it will not be returned for analysis.
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Manufacturer Narrative
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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.Select patient information cannot be provided due to regional privacy regulations.The reported device is not marketed in the united states, but it is a same/similar device to one that is marketed outside the united states.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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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 corrected which was not correct in the initial report.The information has been provided in section b3,b5,h6( hecc,heic) with this report.
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Event Description
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On (b)(6) 2023, customer reported having a low blood glucose of 31mg/dl that was treated with food and glucose tablets.Event occurred yesterday at 12am.Paramedics were called and they gave the customer honey and glucagon.Customer alleged over delivery saying that when pump suspended it delivered insulin.Customer did not receive assistance with programming pump.Last set change was yesterday on an unknown time before the low bg event.Customer was not disconnected during the rewind/prime sequence.Sensor was not used.Pump does not have auto mode feature.Current blood glucose at the time of the call was 189mg/dl.
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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.
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Event Description
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Customer got a new pump and will not continue to use the old pump.Customer will not return the pump for analysis.
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