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 Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Insulin pump received with critical pump error (open book image) after battery insertion due to moisture damage on electronic board stack.Unable to perform displacement test, rewind test, prime/seating test, basic occlusion test, force sensor test, occlusion test, sleep current measurement, active current measurement and selftest due to critical pump errors.Unable to verify basal anomalies or audio/vibrate/absence of alarm anomalies due to critical pump error.Unit received with pillowing keypad overlay, peeling/fading end cap address label and scratched case.Moisture damage on force sensor assembly and on motor assembly.
Event or Problem Description
Information received by medtronic indicated that the customer wanted to make sure that there basal rate was running in the insulin pump.Customer stated that they needs assistance with the insulin pump.No harm requiring medical intervention was reported.The insulin pump will not be returned for analysis.

• 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
• MDR Report Key: 11641619
• Report Number: 2032227-2021-133801
• Device Sequence Number: 3436246
• Product Code: OZP
• UDI-Device Identifier: 00763000283513
• UDI-Public: (01)00763000283513(17)230506
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 04/09/2021

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: 05/06/2023
• Device Model Number: MMT-1780KL
• Device Catalogue Number: MMT-1780KL
• Device Lot Number: HG4AKPZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2021
• Initial Report FDA Received Date: 04/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Weight: 82