MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 630G INSULIN PUMP MMT-1715KL 630G; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number MMT-1715KL

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problems Fatigue (1849); Headache (1880); Hyperglycemia (1905); Nausea (1970); Polydipsia (2604)

Event Date 04/13/2022

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

The customer reported via phone call that they experienced high blood glucose.The customer¿s blood glucose level was over 600 mg/dl at the time of incident.Customer blood glucose level at the time of call was 600 mg/dl.The customer experienced symptoms such as nausea, headache, tiredness and thirst for high blood glucose event.The customer was treated high blood glucose with manual injection.Customer alleged that the insulin pump was under delivering.Customer had been using insulin pump system within 48 hours of reported high blood glucose event.Troubleshooting was performed.The device will not be returned for analysis.No further patient complications were reported.

• Brand Name: 630G INSULIN PUMP MMT-1715KL 630G
• 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: 14155574
• MDR Text Key: 289606652
• Report Number: 2032227-2022-181208
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 000000763000316655
• UDI-Public: (01)000000763000316655(17)241025
• 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: 04/19/2022

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-1715KL
• Device Catalogue Number: MMT-1715KL
• Device Lot Number: HG5UJ1N
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/14/2022
• Initial Date FDA Received: 04/20/2022
• Date Device Manufactured: 10/26/2021
• 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
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 86 KG