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
No Display/Image (1183)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/12/2024 |
Event Type
malfunction
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Event Description
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Information received by medtronic indicated that the customer reported blank display.Troubleshooting was performed.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 pump will not 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.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.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.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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Manufacturer Narrative
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Unit power up properly after battery installation.Proceed it by using a new battery cap and a new battery.P-cap locks properly into the reservoir compartment.The pump passed the displacement test, sleep current test, active current test and self-test.Unit was downloaded successfully using thus software.The power management graph confirmed the unloaded voltage (ul vlith) and loaded voltage (loaded vlith) were within spec range.The adapt tool was utilized to search for any alarms that may have occurred in the past or around the complaint date that might of trigger the reason complain.During download history review no relevant alarms confirm in download history files to confirm complain code.Proceed it by cutting unit open and perform a visual inspection of connectors and electronic stack.All connectors were plugged in properly and no moisture damage or anomalies noted during visual inspection.The following were noted during visual inspection: pillowing keypad overlay, cracked keypad overlay, stained keypad overlay, scratched case and end cap address label missing.In conclusion, customer concern for blank display was not confirmed.Unit successfully powered up after battery installation.No low batt or batt out limit alarms occurred during testing.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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