MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PUMP MMT-1715KM 630G 3ML BLACK MEDI; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number MMT-1715KM

Device Problem Power Problem (3010)

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

Event Date 12/25/2020

Event Type  malfunction  

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.

Event Description

Information received by medtronic indicated that the insulin pump had a critical pump error.Customer stated that insulin pump performed safety and open book image was found.No harm requiring medical intervention was reported.The insulin pump will be returned for analysis.

Manufacturer Narrative

Device received with critical pump error due to corroded electronic assemblies.Unable to perform self test, rewind, seating, basic occlusion test, occlusion test, force sensor test or displacement test due to critical pump error.Device received with corroded battery tube, corroded motor home switch, scratched case, pillowing keypad overlay, cracked battery tube threads, cracked case corner of the belt clip rails near the battery compartment, missing display window cover and cracked keypad overlay.The p-cap does lock properly.

• Brand Name: PUMP MMT-1715KM 630G 3ML BLACK MEDI
• Type of Device: ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
• 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 ; 8185464805
• MDR Report Key: 11099867
• MDR Text Key: 225748688
• Report Number: 2032227-2020-222687
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 000000643169873834
• UDI-Public: (01)000000643169873834
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 02/02/2021

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-1715KM
• Device Catalogue Number: MMT-1715KM
• Device Lot Number: HG1LXR5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2021
• Initial Date Manufacturer Received: 12/25/2020
• Initial Date FDA Received: 12/31/2020
• Supplement Dates Manufacturer Received: 02/02/2021
• Supplement Dates FDA Received: 02/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2017
• 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 Age: 73 YR
• Patient Weight: 124