MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 640G INSULIN PUMP MMT-1711K; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number MMT-1711K

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/27/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer returned pump for an alleged pump error 39 found on (b)(6) 2022.Insulin pump passed active current measurement, sleep current measurement test, self test, rewind, seating, basic occlusion test, occlusion test, force sensor test and displacement test.Pump did not alarm pump error 39 during testing and was not found in pump's downloaded history and traces.Successfully downloaded history files and traces using thus.Pump was cut open to perform visual inspection and found¿ moisture damage¿on the pcba 1, pcba 2, motor and force sensor.Test p-cap and reservoir locked properly into reservoir compartment during testing.The following were noted during visual inspection: pillowing keypad overlay, keypad overlay texture damage and cracked select button keypad overlay.Insulin pump passed required testing.Pump error 39 was not confirmed.The insulin pump involved in this event is the ngp 640g insulin pump which is not marketed in the united states.However, the device is similar to the ngp insulin 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

Information received by medtronic indicated that insulin pump had pump error motor current error detected.Troubleshooting was performed.Customer was able to clear the alarm.Customer was able to complete insulin pump rewind.Customer stated timing of pump error alarm was bolus.No harm requiring medical intervention was reported.The device was returned for analysis.

• Brand Name: 640G INSULIN PUMP MMT-1711K
• 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; * 00777-3869
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386; * 00777-3869
• Manufacturer Contact: tricha miles ; ceiba norte ind. park #50 road; juncos 00777--386 ; * 00777-3869 ; 7635140379
• MDR Report Key: 16002106
• MDR Text Key: 308166854
• Report Number: 2032227-2022-380987
• Device Sequence Number: 1
• Product Code: OYC
• Combination Product (y/n): N
• Reporter Country Code: EZ
• 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
• Report Date: 12/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-1711K
• Device Catalogue Number: MMT-1711K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2022
• Date Manufacturer Received: 11/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2020
• 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