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

Model Number MMT-1715K

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Fatigue (1849); Hyperglycemia (1905); Hypoglycemia (1912); Weakness (2145); Anxiety (2328); Sweating (2444); Shaking/Tremors (2515); Confusion/ Disorientation (2553)

Event Date 11/20/2019

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 customer experienced low blood glucose level.Customer¿s blood glucose was 30 mg/dl at the time of incident.Customer treated with food for low blood glucose.Customer experienced symptoms such as shaking, sweating, anxiety, mental confusion, belligerence, inability to follow simple commands, weakness and fatigue.Customer had using insulin pump system within 48 hours of reported low blood glucose event.Customer was not use auto mode.The customer was neither in the emergency room, nor admitted into hospital as a result of low blood glucose.Based on customer¿s report customer does not allege over delivery.Customer declined troubleshooting for low blood glucose.Customer stated reservoir compartment was broken.The device will not be returned for analysis.

• Brand Name: 630G INSULIN PUMP MMT-1715K 630G BLACK MG
• 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: 9390172
• MDR Text Key: 168450653
• Report Number: 2032227-2019-124583
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00763000190439
• UDI-Public: (01)00763000190439(17)211228
• 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: 11/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/28/2021
• Device Model Number: MMT-1715K
• Device Catalogue Number: MMT-1715K
• Device Lot Number: HG32LT9
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/22/2019
• Date Device Manufactured: 12/29/2018
• 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 Outcome(s): Other
• Patient Age: 22 YR
• Patient Weight: 66