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 Problem
Insufficient Flow or Under Infusion (2182)
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Patient Problems
Hyperglycemia (1905); Muscle Weakness (1967); Vomiting (2144)
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Event Date 04/17/2022 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).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.S/w version 4.11d retainer ring = clear customer returned pump for alleged possible under delivery anomaly found on (b)(6)2022.Insulin pump passed the displacement test, rewind test, prime/seating test, basic occlusion test, force sensor test, occlusion test, self test, and displacement accuracy test.Test p-cap locked into the reservoir tube successfully.No unexpected motor alarms noted during testing.Pump successfully downloaded to thus.No unexpected motor alarms were noted in the history files or traces on the event date.Pump delivered 14.1u of bolus on (b)(6) 2022 and 20.6u of bolus on (b)(6) 2022.The pump was cut open and found dried insulin in the motor slide and moisture on pcba 1 and motor.The following were noted during visual inspection: cracked retainer, cracked keypad overlay, pillowing keypad overlay, stained keypad overlay, cracked case (battery tube), corroded battery tube.Damaged retainer ring confirmed.Possible under delivery anomaly not confirmed in the history files on the event date.Pump passed full dry test.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 insulin pump was under delivering of insulin.Customer was hospitalized on (b)(6) 2022 due to high blood glucose.Customer blood glucose was unknown at the time of incident.Customer was treated with insulin pump, insulin pen and insulin drip for high blood glucose.Customer stated symptoms related to high blood glucose that were vomiting and weakness.No further complications were reported.The insulin pump will be returned for the 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.Insulin pump passed the displacement test, rewind test, prime/seating test, basic occlusion test, force sensor test, occlusion test, self test, and displacement accuracy test.Test p-cap locked into the reservoir tube successfully.No unexpected motor alarms noted during testing.Pump successfully downloaded to thus.No unexpected motor alarms were noted in the history files or traces on the event date.Pump delivered 14.1u of bolus on 14-apr-2022 and 20.6u of bolus on 15-apr-2022.The pump was cut open and found dried insulin in the motor slide and moisture on pcba 1 and motor.The following were noted during visual inspection: cracked retainer, cracked keypad overlay, pillowing keypad overlay, stained keypad overlay, cracked case (battery tube), corroded battery tube.Damaged retainer ring confirmed.Possible under delivery anomaly not confirmed in the history files on the event date.Pump passed full dry test.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.The follow up report was submitted with blank in the g4 section.The correct date is 24-nov-2022.
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