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 Problems Excess Flow or Over-Infusion (1311); Insufficient Flow or Under Infusion (2182)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912)

Event Date 04/23/2022

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.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

The customer reported via phone call that they experienced high blood glucose.The customer¿s blood glucose level was 500 mg/dl at the time of incident.The customer¿s current blood glucose value was 150 mg/dl.The customer did not experienced symptoms due to high blood glucose.The customer treated high blood glucose with insulin pump and injection.The insulin pump was not on auto mode at the time of incident.Customer had been using insulin pump system within 48 hours of reported high blood glucose event.The customer did allege under delivery on insulin pump.Customer also reported the low blood glucose level 21 mg/dl.The customer did not experienced symptoms due to low blood glucose.Customer treated low blood glucose value with food.Customer also did allege over delivery on insulin pump.The customer was neither in the emergency room, nor admitted into hospital as a result of high blood glucose.No further patient complications were reported.Troubleshooting was successfully performed; however, the customer will discontinue use of the device.

• 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: 14313166
• MDR Text Key: 291296232
• Report Number: 2032227-2022-186856
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 000000763000367053
• UDI-Public: (01)000000763000367053(17)240607
• 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: 05/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2022
• 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: HG5DEKX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/27/2022
• Date Device Manufactured: 06/08/2021
• 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: 58 YR
• Patient Sex: Male
• Patient Weight: 136