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 Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Dehydration (1807); Hyperglycemia (1905); Cramp(s) (2193); Diabetic Ketoacidosis (2364)

Event Date 01/21/2020

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¿s mother reported via phone call that the customer was hospitalized for two days due to diabetic ketoacidosis on (b)(6) 2020 at 2.30 pm.The customer blood glucose level was 168 mg/dl.Customer did not want to troubleshoot for high blood glucose value.The customer stated they experienced cramps and dehydration.The customer was treated with insulin drip.Customer stated that insulin pump was not working and had crack from battery opening all the way to the bottom of the insulin pump.Customer stated that the reservoir was lock in place when inserted into insulin pump.The insulin pump will 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; * 00777-3869
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386; * 00777-3869
• Manufacturer Contact: gerwin de graaff ; ceiba norte ind. park #50 road; juncos 00777--386 ; * 00777-3869 ; 8185464805
• MDR Report Key: 9635609
• MDR Text Key: 176548577
• Report Number: 3004209178-2020-60699
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00763000090197
• UDI-Public: (01)00763000090197(17)210424
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 01/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/24/2021
• Device Model Number: MMT-1715K
• Device Catalogue Number: MMT-1715K
• Device Lot Number: HG2H5WE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/21/2020
• Date Device Manufactured: 04/25/2018
• 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
• Treatment: FRN-UNK-RSVR,UNOMED SET
• Patient Outcome(s): Hospitalization
• Patient Age: 24 YR
• Patient Weight: 194