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); No Apparent Adverse Event (3189)

Patient Problems Abdominal Pain (1685); Headache (1880); Hyperglycemia (1905); Nausea (1970); Skin Irritation (2076)

Event Date 12/01/2019

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¿s mother reported via phone call that the customer experienced hyperglycemia.The customer's blood glucose level was over 600 mg/dl at the time of the incident and was treated by just giving bolus.The customer¿s other blood glucose was 334 mg/dl.The customer had nausea, abdominal pain, and headache.The customer was been using insulin pump system within 48 hours of reported high blood glucose event.The insulin pump had an insulin flow block alarm.The customer reported that they do not have a back-up plan available.The customer reported that they feel okay for troubleshooting.The customer was not calling back to perform a high pressure test.The customer does not allege that the insulin pump was under delivering.The customer was advised to change entire set, reservoir and insulin and treat per healthcare professional¿s instructions.The insulin pump 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: 9543555
• MDR Text Key: 174167874
• Report Number: 3004209178-2020-50578
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00763000190439
• UDI-Public: (01)00763000190439(17)211126
• 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: 01/03/2020

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 Expiration Date: 11/26/2021
• Device Model Number: MMT-1715K
• Device Catalogue Number: MMT-1715K
• Device Lot Number: HG2ZQC7
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/28/2019
• Initial Date FDA Received: 01/03/2020
• Date Device Manufactured: 11/27/2018
• 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: 12 YR