MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-754WWS; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
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Model Number MMT-754WWS |
Device Problems
Break (1069); Detachment of Device or Device Component (2907); Material Integrity Problem (2978)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/12/2024 |
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 damage (physical or cosmetic), loose drive support cap, battery cap cracked/damaged.The customer reported that unable to open the battery cap.The customer reported no adverse event.The event involved product(s) mmt-754wws.Troubleshooting was performed and found that driver support cap was damaged, unable to open the battery cap, location of damage was on the battery cap.No harm requiring medical intervention was reported.The customer will discontinue using the insulin pump.Mmt-754wws was requested and customer response was the device will be returned.
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Search Alerts/Recalls
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