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

Model Number MMT-1715KR

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Abdominal Pain (1685); Dyspnea (1816); Hyperglycemia (1905); Hypersensitivity/Allergic reaction (1907); Nausea (1970); Vomiting (2144)

Event Date 12/06/2019

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. 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 the customer experienced hyperglycemia. The customer blood glucose level was 400 mg/dl at the time of incident and customer other blood glucose level was 343 mg/dl. Customer experienced symptoms such as nausea, vomiting, abdominal pain, difficulty breathing and slight allergy. The customer was assisted with troubleshooting and declined. The customer was treated with bolus for high blood glucose. Customer was using insulin pump system within 48 hours of reported high blood glucose event. Customer reported that they alleging insulin pump under delivery. The insulin pump will not be returned for analysis.

• Brand Name: 630G INSULIN PUMP MMT-1715KR 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
• 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: 9451304
• MDR Text Key: 170264852
• Report Number: 2032227-2019-130825
• Device Sequence Number: 1
• Product Code: OZO
• 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

• Type of Report: Initial
• Report Date: 12/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: MMT-1715KR
• Device Catalogue Number: MMT-1715KR
• Device Lot Number: HG304DX
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/06/2019
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 11/30/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 12/11/2019 Patient Sequence Number: 1

Treatment

FRN-UNK-RSVR, UNOMED SET