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
No Display/Image (1183); Visual Prompts will not Clear (2281)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/05/2024 |
Event Type
malfunction
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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.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.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 submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Event Description
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Information received by medtronic indicated that the customer reported the insulin pump vibrated and there was a red light and had a no display.Troubleshooting was performed.The customer called back after installing a new battery and monitoring the pump for 2 hours and the frozen display recurred.No harm requiring medical intervention was reported.The customer will discontinue the use of the device and revert to the backup plan as per health care professional instructions.The insulin pump will be returned for analysis.
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Manufacturer Narrative
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P-cap locked in place properly during testing.Unit powered up normally and function properly during battery installation.Unit passed displacement test.Unit received with serial number label missing, keypad overlay texture damage, battery tube threads - cracked, cracked case (battery tube), cracked case-corner of belt clip rails, cracked keypad overlay, stained keypad overlay, and pillowing keypad overlay.In summary, customer allegation for blank screen and frozen screen were not confirmed due to pump powering up properly.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of 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.Medtronic will submit a supplemental report if additional relevant information becomes known.
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