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
Unintended Movement (3026)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/24/2022 |
Event Type
malfunction
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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 received a pump error 130.No harm requiring medical intervention was reported.Troubleshooting was performed and was able to clear the alarm successfully.And the customer was able to rewind the insulin pump.The customer will discontinue using the insulin pump and will 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.Additional information has been received which was not included with the initial report.The information has been provided in section b5 with this report.Retainer = black.Case type = ngp the customer alleged pump error 130 event date of (b)(6) 2022.Unit passed displacement test, rewind test, prime/seating test.Basic occlusion test, force sensor test, occlusion test.Successfully download history files and traces using thus.Pump error 130 was noted on 11/24/2022 16:21:55.000.The pump was cut open to perform a visual inspection and found no evidence of physical or moisture damage on the electronic assembly, motor, or force sensor.Test p-cap and reservoir locked properly into reservoir compartment during testing.The following were noted during visual inspection: battery tube threads - cracked.Cracked case (battery tube).Cracked case-corner of belt clip rails.Pillowing keypad overlay pump error 130 not confirmed 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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Information received by medtronic indicated that the insulin pump had a movement in hall sensor counts that are unexpected since the pump did not command motor movement error alarm.Customer performed displacement test.Insulin pump did not pass the test.It was reported that the insulin pump was returned for analysis.
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