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
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information that battery cap cracked/damaged, blank display occurred.There was no adverse impact or consequence reported as a result of this event.
Additional Manufacturer Narrative
2032227-060322-002-c.(b)(4).S.W version 4.10e.The pump was received with a scratched case, a cracked keypad overlay, a cracked case-corner of belt clip rails near the battery compartment, a pillowing keypad overlay and a serial number label fading.The test reservoir does lock properly inside the reservoir tube.Unable to confirm battery cap damage due to pump received without the original battery cap.A test battery cap locks securely into place.The pump powered up properly after battery installation.No blank display noted.The pump passed the displacement test, sleep current measurement, active current measurement and self test.The pump was received with normal operating currents.The pump was monitored for several hours and no unexpected powering off or blank display noted.

• 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: 14824059
• Report Number: 2032227-2022-240058
• Device Sequence Number: 19469193
• Product Code: OZP
• UDI-Device Identifier: 00763000283506
• UDI-Public: (01)00763000283506(17)221023
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 06/26/2022

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: 10/23/2022
• Device Model Number: MMT-1780KL
• Device Catalogue Number: MMT-1780KL
• Device Lot Number: HG3VCML
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2020
• Initial Report FDA Received Date: 06/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2019
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2032227-060322-002-C
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Sex: Unknown
• Patient Weight: 170