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 Problems
Device Alarm System (1012); Break (1069); No Display/Image (1183); Moisture or Humidity Problem (2986)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/10/2024 |
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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It was reported to medtronic minimed that the customer experienced beeping and vibration with a blank display.Exposed to moisture, damage (physical or cosmetic), audio/vibrate anomaly/absence of alarm, blank display.The customer reported no adverse event.The event involved product(s) mmt-1712kl.Troubleshooting was performed for the reported events.The customer reported a beeping and vibration with a blank display.Battery cap contacts and battery compartment and or springs were not damaged.The customer stated that the insulin pump was recently exposed to moisture.The display did not return after inserting a new battery.The customer reported physical damage or crack in the backside of the battery compartment.No harm requiring medical intervention was reported.A product return for mmt-1712kl was requested and the customer response was the pump will be returned.
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