MEDTRONIC PUERTO RICO OPERATIONS CO. 640G INSULIN PUMP MMT-1712K; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
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Model Number MMT-1712K |
Device Problems
Excess Flow or Over-Infusion (1311); Insufficient Flow or Under Infusion (2182)
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Patient Problems
Hyperglycemia (1905); Hypoglycemia (1912)
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Event Date 01/20/2023 |
Event Type
malfunction
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Event Description
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Information received by medtronic indicated that the customer experienced an increase and decrease in blood glucose values.The customer doubted the functionality of the pump.No further details were provided.Troubleshooting was not performed.No harm requiring medical intervention was reported.It was unknown whether the customer will continue using the pump.The pump will not be returned for analysis.
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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.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.The insulin pump involved in this event is the ngp 640g insulin pump mmt-1712k which is not marketed in the united states.However, the device is similar to the ngp insulin 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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Manufacturer Narrative
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Unit passed active current measurement, sleep current measurement test, self-test, rewind, seating, basic occlusion test, occlusion test, force sensor test and displacement test.Unit passed dat test at 0.08765 inches.No over/under delivery anomalies noted during testing.Unit successfully downloaded to thus and carelink.Confirmed 22.15 units of normal bolus was delivered on 01/20/2023 between 01:33:08.000 and 01:33:08.000.The electronic assemblies and motor assemblies were inspected, and no anomalies noted.The following were noted during visual inspection: corroded battery tube, cracked reservoir retainer ring, scratched case, pillowing keypad overlay, and stained serial number label.The p-cap/reservoir does lock properly.Pump passed functional testing.No over or under delivery anomalies noted during testing.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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Updated description: the pump was returned for analysis.
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