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

Model Number MMT-754DES

Device Problems Excess Flow or Over-Infusion (1311); Insufficient Flow or Under Infusion (2182); Appropriate Term/Code Not Available (3191)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912)

Event Date 01/20/2023

Event Type  malfunction  

Event Description

Information received by medtronic indicated that the customer experienced hypoglycemia and hyperglycemia.The customer also reported that the insulin pump was overdelivering and underdelivering the insulin.The blood glucose value was 29 mg/dl at the time of the event.Troubleshooting was not performed.It was unknown whether the customer was using the insulin pump within 48 hours of the event.No further patient complications were reported.It was unknown whether the customer would continue using the insulin pump.The insulin pump will not be returned for analysis.

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.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.

Event Description

Device was returned for analysis.

Manufacturer Narrative

Select patient information cannot be provided due to regional privacy regulations.Additional information has been received which was not included with the initial report.The information has been provided in section b5 with this report (b)(4).On jan 20, 2023 customer returned pump for an alleged underdelivering.High bg/under/over delivery unit received with all operating currents within spec ¿stop idle current, run current, self test, off no power¿.And passed functional testing including the rewind, a21 error test with basic occlusion test with occlusion test, with prime/a33 test, excessive no delivery test and displacement test.Pump history download using thds was successful however, on (b)(6) 2023 there is no alarm reports event date noted.Unit was downloaded to care link pro properly and all bolus delivered were found at the care link report.The following were noted during visual inspection: cracked belt clip slot and cracked reservoir tube lip.The test p-cap/reservoir does lock into place.No moisture damage found on the electronics, motor, battery tube and vibrator assembly noted.Pump passed the dat test at 0.0876 inches.No possible over/under delivery anomaly noted.(not confirmed).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.The information that provided with the initial report was incorrect.The correct information has been included with this report in h10 section.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-754DES
• 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: 16332765
• MDR Text Key: 309128711
• Report Number: 2032227-2023-148417
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 000000763000161248
• UDI-Public: (01)000000763000161248
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-754DES
• Device Catalogue Number: MMT-754DES
• Device Lot Number: B0754DESJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 03/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/29/2020
• 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
• Patient Outcome(s): Other