MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PUMP MMT-1715KM 630G 3ML BLACK MEDI; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number MMT-1715KM

Device Problems Circuit Failure (1089); Insufficient Flow or Under Infusion (2182); Obstruction of Flow (2423)

Patient Problems Hyperglycemia (1905); Anxiety (2328)

Event Date 11/19/2020

Event Type  malfunction  

Manufacturer Narrative

Pump passed the rewind test, prime/seating test, basic occlusion test, occlusion test, force sensor test, self test and displacement test.No unexpected no delivery/insulin flow blocked alarm noted during testing.Hardware low level failures alarm (variableinfo=3) confirmed in the pump history due to broken trace on u1 keypad assembly.(b)(4).

Event Description

Information received by medtronic indicated that insulin pump had hardware low level failures alarm during self test.Customer was able to successfully clear the alarm.Customer was able to complete rewind.Customer alleging insulin pump was under delivery due to blood glucose was rising.No harm requiring medical intervention was reported.The customer was assisted with troubleshooting.Customer experienced high blood glucose and treated with manual injection.The device will be returned for analysis.

• Brand Name: PUMP MMT-1715KM 630G 3ML BLACK MEDI
• Type of Device: 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: gerwin de graaff ; ceiba norte ind. park #50 road; juncos 00777--386 ; * 00777-3869 ; 8185464805
• MDR Report Key: 11025546
• MDR Text Key: 222004052
• Report Number: 2032227-2020-218333
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 000000643169873834
• UDI-Public: (01)000000643169873834
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-1715KM
• Device Catalogue Number: MMT-1715KM
• Device Lot Number: HG2K6DU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2020
• Date Manufacturer Received: 12/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 83 YR