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

Model Number MMT-1712K

Device Problem No Display/Image (1183)

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

Event Date 03/04/2024

Event Type  malfunction  

Manufacturer Narrative

This mdr related to the puerto rico manufacturing site has been assigned a medwatch number from the medtronic minimed northridge site, per variance 5.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.Select patient information cannot be provided due to regional privacy regulations.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of 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.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Information received by medtronic indicated that the customer reported a blank display and was impossible to switch on the insulin pump even with a fresh lithium battery.No further details were provided.Troubleshooting could not be performed.No harm requiring medical intervention was reported.The customer will discontinue using the insulin pump and the pump will be returned for analysis.

Manufacturer Narrative

The pump passed the sleep current measurement, active current measurement, self-test.Unable to perform displacement test due to missing retainer ring.Successfully downloaded the trace and history files using thus.No blank display noted during test.The power management graph confirmed abnormal unloaded voltage (ul vlith) and loaded voltage (loaded vlith) due to moisture damage to pcb1 and pcb2 board.No alarms or alerts noted during testing or in the history download files.Pump was cut open to perform visual inspection and found moisture damage¿to the motor assemblies, pcb1 board and pcb 2 board.Test p-cap and reservoir was unable to locked properly into reservoir compartment due to missing retainer ring.The following were noted during visual inspection: scratched case, pillowing keypad overlay, corroded battery tube, corroded motor home switch, missing o-ring(reservoir tube), detached retainer, cracked retainer.Blank display was not observed.However, missing retainer ring was noted during test and the power management graph confirmed abnormal unloaded voltage (ul vlith) and loaded voltage (loaded vlith) due to moisture damage to pcb1 and pcb2 board.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: 640G INSULIN PUMP MMT-1712K
• 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: lusine boyadzhyan ; ceiba norte ind. park #50 road; juncos 00777--386 ; * 00777-3869
• MDR Report Key: 18928511
• MDR Text Key: 338143390
• Report Number: 2032227-2024-144766
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 000000643169577688
• UDI-Public: (01)000000643169577688
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• 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: 03/19/2024

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-1712K
• Device Catalogue Number: MMT-1712K
• Device Lot Number: HG0HQNM
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/11/2024
• Initial Date FDA Received: 03/19/2024
• Date Device Manufactured: 06/26/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1