MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 670G INSULIN PUMP MMT-1780KL; ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL

Model Number	MMT-1780KL
Medical Device Problem Codes	Battery Problem (2885); Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Information received by medtronic indicated that insulin pump had replace battery alert.Customer was changing batteries and alarm occurred.There was second occurrence of replace battery now alarm or off no power alarm prior low battery alert.The battery cap was not loosed or damaged.No harm requiring medical intervention was reported.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Retainer ring = black the crest downloads were successful.Pump received with constant critical pump error (open book) and unsuccessful to download to thus.Unable to perform the functional test, including the self test, sleep current measurement, active current measurement, rewind test, prime/seating test, basic occlusion test, occlusion test, force sensor test and displacement test due to constant critical pump error (open book).Pump was cut/open to perform visual inspection and found moisture damage at the pcb1 and pcb2.Also moisture damage at the force sensor.Pump error 35 alarm found in the pump history due to force sensor moisture damage.On (b)(6) 2021 23:54:49.000 alarmalertnotification faultnumber = broken force sensor error (35).On (b)(6) 2021 00:04:00.000 alarmalertnotification faultnumber = broken force sensor error (35).Formatted history file lists data from (b)(6) 2021 to (b)(6) "202." there are no date listed on (b)(6) 2019.Unable to verify unexpected battery power loss anomaly or low battery alarm due to no date available on (b)(6) 2019.The long trace, pump history and sensor history was uploaded properly.However, the detail trace history unable to uploaded due to constant vibration and black display screen due moisture damage at the electronic assembly.Attempted to re - download 2nd time on thus by switching board.Original pcb2 and test pcb1.Try to download and unsuccessful to download to thus due moisture damage.Pump received with cracked select button keypad overlay.Test reservoir/pcap lock properly inside the reservoir tube.(b)(4).

• Brand Name: 670G INSULIN PUMP MMT-1780KL
• Common Device Name: ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL
• 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: 12710430
• Report Number: 2032227-2021-211435
• Device Sequence Number: 14692053
• Product Code: OZP
• UDI-Device Identifier: 00763000283513
• UDI-Public: (01)00763000283513(17)221107
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 10/28/2021

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 Expiration Date: 11/07/2022
• Device Model Number: MMT-1780KL
• Device Catalogue Number: MMT-1780KL
• Device Lot Number: HG3X2JW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2021
• Initial Report FDA Received Date: 10/28/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2019
• 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: 61 YR
• Patient Sex: Female
• Patient Weight: 180