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 Insufficient Flow or Under Infusion (2182)

Patient Problem Hyperglycemia (1905)

Event Date 04/22/2022

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.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.

Event Description

It was reported that customer experienced high blood glucose level.Customer's blood glucose value was 22 mmol/l at the time of the incident.Another blood glucose level was 10.1 mmol/l.The customer was assisted with troubleshooting for high blood glucose.The customer was treated with manual injection.Customer had been using insulin pump system within 48 hours of reported high blood glucose event.Customer did allege insulin pump was under delivering as they had high blood glucose when on pump.No further complications were reported.The customer will continue to use the product.

• 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; * 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: 14234054
• MDR Text Key: 290263049
• Report Number: 2032227-2022-184514
• 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: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-1714K
• Device Catalogue Number: MMT-1714K
• Device Lot Number: HG5UMRW
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/22/2022
• Date Device Manufactured: 10/27/2021
• 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-MMT-332-RSVR, UNOMED INF SET
• Patient Outcome(s): Other