MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-754LCAS; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number MMT-754LCAS

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problems Fever (1858); Headache (1880); Hyperglycemia (1905); Nausea (1970)

Event Date 03/20/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.The insulin pump involved in this event is the paradigm real-time veo insulin infusion pump, which is not marketed in the united states.However, the device is similar to the paradigm real-time insulin infusion pump, which is marketed in the united states.

Event Description

Information received by medtronic that the insulin pump had under delivery.The customer¿s blood glucose value was 20 mmol/l.Customer¿s current blood glucose is 13 mmol/l.The customer did not experience any symptoms such nausea, fever, headache result of high blood glucose.Troubleshooting was done for high blood glucose and under delivery.Based on customer report customer does allege pump was under delivering because of high blood glucose value.No further complications were reported.The customer will continue to use the device.

Event Description

Information received by medtronic that the insulin pump had under delivery.The customer¿s blood glucose value was 20 mmol/l.Customer¿s current blood glucose is 13 mmol/l.The customer did not experience any symptoms such nausea, fever, headache result of high blood glucose.Customer visited to emergency room and hospitalized overnight.Customer was hospitalized at unknown date with 20 mmol/l blood glucose value.Customer treated high blood glucose level with intravenous insulin drip.Troubleshooting was done for high blood glucose and under delivery.Based on customer report customer does allege pump was under delivering because of high blood glucose value.No further complications were reported.Customer stated the displacement test was passed.The customer will continue to use the device.

Manufacturer Narrative

Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.Medtronic objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Information has been corrected which was not correct in the initial report.The information has been provided in section b5 with this report.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-754LCAS
• Type of Device: PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386
• Manufacturer Contact: tricha miles ; ceiba norte ind. park #50 road; juncos 00777--386 ; 7635140379
• MDR Report Key: 13937329
• MDR Text Key: 289342831
• Report Number: 2032227-2022-173097
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 000000763000084363
• UDI-Public: (01)000000763000084363
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-754LCAS
• Device Catalogue Number: MMT-754LCAS
• Device Lot Number: A2754LCASJ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1