MEDTRONIC PUERTO RICO OPERATIONS CO. MINIMED 720G OUS BLE CONNECT 3.0 MGDL; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
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Model Number MMT-1810 |
Device Problems
Device Alarm System (1012); No Display/Image (1183); Display or Visual Feedback Problem (1184)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/22/2024 |
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.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.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.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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It was reported to medtronic minimed that the customer experienced blank display and vibrate anomaly.The customer reported no adverse event.The event involved product(s) mmt-1810.Troubleshooting was performed.Customer reported a blank display, constantly vibrating, led control light is blinking.Battery cap contacts and battery compartment and/or springs were not damaged.Display did not return after pump restart.No harm requiring medical intervention was reported.Mmt-1810 was requested and customer response was the device will be returned.The customer will discontinue the use of the device.
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Manufacturer Narrative
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Pump received with blank display.Unable to perform the displacement test, sleep current test, active current test and self test due to blank display.Unable to download history files and traces using [thump] due to blank display.Pump was cut open to perform visual inspection and found a crack on the u6 chip.Test p-cap and reservoir locked properly into reservoir compartment during testing.The following were noted during visual inspection: scratched case, pillowing keypad overlay, and cracked battery tube threads.Unable to verify audio/vibrate anomaly/absence of alarm and led anomaly due to blank display.Blank display was confirmed during analysis due to a cracked u6 chip.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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