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	Mechanical Problem (1384)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	05/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The customer alleged pump error on (b)(6) 2020.The customer mentioned high blood glucose.The pump passed 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, displacement test and the dat at 0.0871 inches.No pump error noted during testing.There is no data available for the event date in the formatted history file.Unable to verify pump error in the formatted history file.The following were noted during visual inspection: minor scratched display window, missing display window cover, scratched case, cracked battery tube threads, cracked case at corner of the belt clip rail, keypad overlay texture damage, pillowing keypad overlay, cracked keypad overlay at the select button and partially broken off retainer.The test p-cap and reservoir does lock in place in the reservoir compartment.History download was successful using thus.During visual inspection, no damage noted on the electronic assembly, motor or force sensor.The motor was tested outside of the pump and passed.The customer alleged pump error was not confirmed.Unable to confirm alleged high blood glucose.
Event or Problem Description
Information received by medtronic indicated that the insulin pump had pump error.It was reported that the customer was able to clear the alarm.No harm requiring medical intervention was reported.The customer discontinued the use of device.

• 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: 14427051
• Report Number: 2032227-2022-191271
• Device Sequence Number: 5488215
• Product Code: OZP
• UDI-Device Identifier: 00763000283513
• UDI-Public: (01)00763000283513(17)230227
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 05/17/2022

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: 02/27/2023
• Device Model Number: MMT-1780KL
• Device Catalogue Number: MMT-1780KL
• Device Lot Number: HG44YES
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2022
• Initial Report FDA Received Date: 05/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2020
• 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: 51 YR
• Patient Sex: Male
• Patient Weight: 73 KG