MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PUMP MMT-1714K 630G BLACK MMOL CANADA; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number MMT-1714K

Device Problem Obstruction of Flow (2423)

Patient Problems Hyperglycemia (1905); Nausea (1970)

Event Date 12/02/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned.The device will be returned for analysis and further information will follow once the analysis has been completed.No conclusion can be drawn at this time.

Event Description

It was reported via phone call that customer experienced high blood glucose level.Customer blood glucose level at time of incident was 25 mmol/l customer current blood glucose level was 22.5 mmol/l.The customer was treated with insulin pump and manual injection.Customer had been using insulin pump system within 48 hours current of reported high blood glucose event.Customer stated that the auto mode feature was not active at the time of high blood glucose event.The customer was neither in the emergency room, nor admitted into hospital as a result of high blood glucose.Customer stated that insulin pump had insulin flow blocked alarm and insulin exited.Customer reporting symptoms related to their high blood glucose was nausea.Customer was assisted with troubleshooting for high blood glucose.The device will be returned for analysis.

Manufacturer Narrative

Device passed the displacement test, rewind test, prime/seating test, basic occlusion test, force sensor test, occlusion test and self test.Device was programmed with multiple bolus deliveries and all bolus delivered properly their indicated amounts and were properly recorded in the daily history.No unexpected occlusions or insulin flow blocked alarm noted during testing.(b)(4).

• Brand Name: PUMP MMT-1714K 630G BLACK MMOL CANADA
• 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
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386
• Manufacturer Contact: gerwin de graaff ; ceiba norte ind. park #50 road; juncos 00777--386 ; 8185464805
• MDR Report Key: 10957591
• MDR Text Key: 219848864
• Report Number: 2032227-2020-213778
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 000000763000315702
• UDI-Public: (01)000000763000315702
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-1714K
• Device Catalogue Number: MMT-1714K
• Device Lot Number: HG3Z29F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/02/2020
• Initial Date FDA Received: 12/07/2020
• Supplement Dates Manufacturer Received: 01/25/2021
• Supplement Dates FDA Received: 01/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2019
• 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
• Treatment: FRN-UNK-RSVR, UNOMED SET
• Patient Outcome(s): Other