MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723LNAS; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
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Model Number MMT-723LNAS |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)
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Patient Problem
Hypoglycemia (1912)
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Event Date 03/12/2024 |
Event Type
Injury
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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.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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Event Description
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It was reported to medtronic minimed that the customer experienced no alleged device deficiency.The customer reported hypoglycemia treated with emergency medical service/ambulance/emergency room visit.The event involved product(s) unomedical, mmt-723lnas, mmt-332a.Troubleshooting was declined.It was unknown if the customer was using the pump within 48 hours of the reported event.The auto mode/smartguard feature was not active.No further patient complications were reported.No product return is required for unomedical.No product return is required for mmt-723lnas.No product return is required for mmt-332a.
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Manufacturer Narrative
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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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Customer wanted to know how to fill the reservoir with insulin while she was having a low blood glucose.She said she has trouble with comprehension when she is having a low.Customer was hard of hearing and was having problem following instruction and sounded disoriented.Helpline supervisor called the paramedics with customer's permission.Call got disconnected after the paramedics said "hello".Helpline tried calling back but was sent to voicemail.Pump does not have auto mode/smartguard feature.It was unknown if customer will continue to use the pump.Pump is not returning for analysis.
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