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

Model Number MMT-1715KL

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); Hypoglycemia (1912); Nausea (1970); Skin Irritation (2076); Vomiting (2144); Blood Loss (2597)

Event Date 08/07/2019

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 the customer was in emergency room due to hyperglycemia on an unknown date.The customer¿s blood glucose level was unknown at the time of hospitalized and the blood glucose level at the time of incident was 510 mg/dl.The customer was assisted with troubleshooting.Customer has been using insulin pump system within 48 hours of reported high blood glucose event.The customer experienced symptoms such as nausea, vomiting, abdominal pain, difficulty breathing, chest burning pain and skin irritation.The customer was treated with insulin.Customer reported that they have contacted their healthcare professional regarding the high blood glucose level.Customer was unable to complete carelink upload.The insulin pump will not be returned for analysis.

• Brand Name: 630G INSULIN PUMP MMT-1715KL 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: 8919753
• MDR Text Key: 155178765
• Report Number: 2032227-2019-50936
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00763000166519
• UDI-Public: (01)00763000166519(17)220220
• 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: 08/22/2019

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: 02/20/2022
• Device Model Number: MMT-1715KL
• Device Catalogue Number: MMT-1715KL
• Device Lot Number: HG36S1U
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/13/2019
• Initial Date FDA Received: 08/22/2019
• Date Device Manufactured: 02/21/2019
• 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 INF SET
• Patient Outcome(s): Other
• Patient Age: 28 YR
• Patient Weight: 115