MEDTRONIC PUERTO RICO OPERATIONS CO. 640G INSULIN PUMP MMT-1711K; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
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Model Number MMT-1711K |
Device Problems
Insufficient Flow or Under Infusion (2182); Appropriate Term/Code Not Available (3191)
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Patient Problems
Hyperglycemia (1905); Nausea (1970); Malaise (2359); Diabetic Ketoacidosis (2364); Polydipsia (2604)
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Event Date 09/27/2022 |
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.The insulin pump involved in this event is the 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.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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Information received by medtronic indicated that the customer experienced high blood glucose on (b)(6), 2022 with blood glucose level at 30 mm0l/l at the time of event.Customer reported unwell, thirsty, nauseate symptoms.Customer was treated with iv insulin drip at hospital for hyperglycemia.Customer stated that insulin pump had been under delivering and the insulin pump system was in use within 48 hours of reported hyperglycemic event.Troubleshooting was performed and displacement test and hp test were passed.No further customer complications were reported.The insulin pump will be returned for analysis.
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Manufacturer Narrative
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Retainer ring = clear.Case type = ngp.Customer returned insulin pump for an alleged possible under delivery and was hospitalized for high blood glucose found on september 27, 2022.The insulin pump passed the functional tests, 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 delivery accuracy test at 0.08760 inches.Successfully downloaded history files and traces using thus.Successfully uploaded insulin pump to carelink.In further full review of the insulin pump history/traces on the event date of september 27, 2022, there was no unexpected alarms/suspends noted and found bolus delivery of dailytotalofbolusinsulindelivered = 29.9 u.September 27, 2022 10:02:12.000 normalbolusdelivered normalbolusamountprogrammed = 1.5 bolusamountdelivered = 1.5.September 27, 2022 10:50:28.000 normalbolusdelivered normalbolusamountprogrammed = 1.8 bolusamountdelivered = 1.8.September 27, 2022 11:22:24.000 normalbolusdelivered normalbolusamountprogrammed = 2.7 bolusamountdelivered = 2.7.September 27, 2022 12:38:22.000 normalbolusdelivered normalbolusamountprogrammed = 2.3 bolusamountdelivered = 2.3.September 27, 2022 13:32:58.000 normalbolusdelivered normalbolusamountprogrammed = 2.7 bolusamountdelivered = 2.7.September 27, 2022 14:53:14.000 normalbolusdelivered normalbolusamountprogrammed = 2.1 bolusamountdelivered = 2.1.September 27, 2022 15:17:16.000 normalbolusdelivered normalbolusamountprogrammed = 4.4 bolusamountdelivered = 4.4.September 27, 2022 15:51:50.000 normalbolusdelivered normalbolusamountprogrammed = 2.9 bolusamountdelivered = 2.9.September 27, 2022 16:46:54.000 normalbolusdelivered normalbolusamountprogrammed = 4.6 bolusamountdelivered = 4.6.September 27, 2022 16:56:06.000 normalbolusdelivered normalbolusamountprogrammed = 2.3 bolusamountdelivered = 2.3.September 27, 2022 17:34:48.000 normalbolusdelivered normalbolusamountprogrammed = 2.6 bolusamountdelivered = 2.6.The insulin pump was programmed with multiple bolus deliveries and all bolus delivered properly their indicated amounts (at quick bolus speed) and were properly recorded in the daily history.No bolus delivery anomaly or history anomaly noted.No under delivery anomaly or over delivery anomaly noted during testing.Insulin pump was cut open to perform visual inspection and found no evidence of physical or moisture damage on the electrical board1, electrical board2, force sensor, motor and vibrator assembly noted.Force sensor zero offset within specification (22.8 mv).The motor was tested outside of the device on the ngp stb3 and passed.The test p-cap and reservoir locked properly into reservoir compartment.However, a cracked retainer was noted during testing.The following were also noted during visual inspection: a cracked keypad overlay, a pillowing keypad overlay and a scratched case.A cracked retainer was confirmed.The insulin pump passed all the required testing.Unable to verify customer alleged for high blood glucose.The force sensor is within specification and the motor functioning properly.Customer alleged for possible under delivery was not confirmed.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.This mdr related to the puerto rico manufacturing site has been assigned a medwatch number from the medtronic minimed northridge site, per variance 5.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.Initial report was submitted with missing information.The corrected information has been updated and provided with this report in section b5.
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Event Description
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The device was returned for the 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 h6 under health effect - clinical code with this report.
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