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

Model Number MMT-754WWS

Device Problems Premature Discharge of Battery (1057); Mechanical Problem (1384)

Patient Problems Dehydration (1807); Hyperglycemia (1905); Vomiting (2144)

Event Date 08/06/2022

Event Type  Injury  

Event Description

Information received by medtronic indicated that insulin pump alarmed motor error, more than once.Customer stated that the insulin pump alarmed unexpected restart.A cold reset was performed when batteries where changed and also all settings were deleted and need to reset.Customer was dispatched through ambulance for high blood glucose.Customer was throwing up all nigh with blood glucose value 20 mmol/l.Customer was treated with intravenous and was dehydrated and had elevated ketones but was not diagnosed as diabetic ketoacidosis.Customer stated that the insulin pump passed self and displacement test.No further patient complications were reported.The insulin pump will 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.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.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.

Manufacturer Narrative

The customer was treated by the ambulance for alleged elevated ketones on august 06, 2022.The customer reported motor error alarm, insulin pump error alarm and settings were deleted after battery change.The insulin pump passed the displacement test, rewind test, basic occlusion test, occlusion test, prime/insulin pump error test, excessive no delivery test and delivery accuracy test at 0.0872 inches.The stop (idle) current and run current measurement tests are within specification.The insulin pump also passed self test and off no power alarm test.There was no insulin pump error alarm on the event date in the insulin pump history file.However, during the insulin pump error error test, the insulin pump alarm insulin pump error after the battery insertion and the insulin pump reset time/date to factory default due to faulty c13 leaking and corroding the i/b.No motor error alarm noted during testing.However, motor error alarm were noted in the insulin pump history file on the event date.August 06, 2022 09:06:09 alarm # - alarm_motor_error - motor error - the gearbox is stuck, need to rewind.August 06, 2022 09:18:25 alarm # - alarm_motor_error - motor error - the gearbox is stuck, need to rewind.The motor was tested outside of the insulin pump and passed.Motor may have an intermittent failure that was not detected during testing.Motor error alarm, problem isolated to the motor.The following were noted during visual inspection: missing end cap sticker.The test p-cap and reservoir does lock in place in the reservoir compartment.History download was successful using thds and carelink upload was successful.The insulin pump passed all the testing, except the insulin pump error error test.Unable to confirm alleged ketones.Motor error alarm confirmed.Insulin pump error alarm confirmed.Insulin pump reset time/date settings to factory default 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.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-754WWS
• 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: 15361742
• MDR Text Key: 299287079
• Report Number: 2032227-2022-324229
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 000000763000161286
• UDI-Public: (01)000000763000161286
• Combination Product (y/n): N
• Reporter Country Code: SI
• 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: 11/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-754WWS
• Device Catalogue Number: MMT-754WWS
• Device Lot Number: B8754WWSJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 08/09/2022
• Initial Date FDA Received: 09/06/2022
• Supplement Dates Manufacturer Received: 11/04/2022
• Supplement Dates FDA Received: 11/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2018
• 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