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 Hypoglycemia (1912); Seizures (2063)

Event Date 01/10/2020

Event Type  Injury  

Manufacturer Narrative

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.(b)(4).

Event Description

The customer reported via phone call that they were hospitalized for low blood glucose and seizure.The customer's blood glucose level at the time of incident was in between 30mg/dl to 40 mg/dl.Customer was treated with food and sugar water.Customer also stated that the clip was broken.The insulin pump will not be returned for analysis.

Manufacturer Narrative

The initial report had the incorrect information.(b)(4).

Event Description

Customer stated that they only dispatched emergency medical service.Customer was not hospitalized.

• 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
• MDR Report Key: 9846617
• MDR Text Key: 183888631
• Report Number: 3004209178-2020-87252
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00763000090197
• UDI-Public: (01)00763000090197(17)210712
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 06/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/12/2021
• Device Model Number: MMT-1715K
• Device Catalogue Number: MMT-1715K
• Device Lot Number: HG2NPLL
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FRN-MMT 332A UNOMED SET; FRN-MMT 332A UNOMED SET
• Patient Outcome(s): Hospitalization
• Patient Age: 60 YR
• Patient Weight: 190