MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 640G INSULIN PUMP DEMMT-1712K 640G BLACK MG; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number DEMMT-1712K

Device Problems Erratic or Intermittent Display (1182); Display or Visual Feedback Problem (1184)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/17/2018

Event Type  malfunction  

Manufacturer Narrative

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 640g 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

It was reported that the insulin pump had a flash, solid white.The customer¿s blood glucose level was unknown time of the incident.Troubleshooting was not performed and display did not return after pump restart.The insulin pump will be returned for analysis.

Manufacturer Narrative

Retainer ring = missing customer returned device for an alleged missing segments found on may 17, 2018 device received with blank display.Unable to perform the displacement test, sleep current test, active current test and self test due to blank display.Unable to download history files and traces due to blank display.Pump was cut open to perform visual inspection and found no evidence of physical or moisture damage on the electronic assembly, motor, or force sensor.Swapping out test boards confirms blank display is isolated to electric board.Device powered on successfully, however, missing segments was confirmed due to a cracked screen.Device test p-cap and reservoir was unable to lock properly into reservoir compartment during testing due to a missing retainer ring.The following were noted during visual inspection: pillowing keypad overlay, scratched case, cracked case (battery tube), battery tube threads cracked, cracked keypad overlay, keypad overlay texture damage, detached retainer, cracked glass and minor scratches.In summary customers alleged missing segments was confirmed due to electric board 1 after swapping electric board 2 to power the device back on.Blank display was confirmed and isolated to electric board 2.Unable to download history files and traces due to blank display.Additionally, missing retainer ring was noted.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: 640G INSULIN PUMP DEMMT-1712K 640G BLACK MG
• 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: gerwin de graaff ; ceiba norte ind. park #50 road; juncos 00777--386
• MDR Report Key: 7595029
• MDR Text Key: 111236559
• Report Number: 3004209178-2018-80414
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00643169589438
• UDI-Public: (01)00643169589438
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 11/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DEMMT-1712K
• Device Catalogue Number: DEMMT-1712K
• Device Lot Number: A000339060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2015
• 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