MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-751LNAS; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number	MMT-751LNAS
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Customer complaint notes, customer called in because of the motor error inquired what led up to the complaint.Pump history download using thds was successful.However, pump error alarms found on the history file which caused corrupted data.Unable to confirm the reported event date due to the corrupted data.Pump error alarms are due to the pump not having power for a long period of time.Pump passed the displacement test, rewind, basic occlusion, occlusion, prime and excessive no delivery test.No motor error alarm noted.Motor passed motor test.No moisture damage found on the electronics, motor, battery tube and vibrator assembly noted.Pump received with cracked belt clip slot, missing end cap sticker, stained address/serial number label and cracked reservoir tube lip.The test p-cap/reservoir does lock into place.
Event or Problem Description
Information received by medtronic indicated that the insulin pump had a motor error alarm.Customer stated they were able to clear the alarm and able to rewind the insulin pump.No harm requiring medical intervention was reported.The insulin pump will be returned for analysis.

• Brand Name: 530G INSULIN PUMP MMT-751LNAS
• Common Device Name: ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
• 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: 12750555
• Report Number: 2032227-2021-214383
• Device Sequence Number: 14379746
• Product Code: OZO
• UDI-Device Identifier: 00643169933224
• UDI-Public: (01)00643169933224
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/04/2021

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
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-751LNAS
• Device Catalogue Number: MMT-751LNAS
• Device Lot Number: A5751LNASJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2021
• Initial Report FDA Received Date: 11/04/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 28 YR
• Patient Sex: Male
• Patient Weight: 73 KG