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 Hyperglycemia (1905); Diabetic Ketoacidosis (2364); Blood Loss (2597)

Event Date 12/31/2019

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.

Event Description

Customer reported via phone call that they experienced hyperglycemia.Customer's blood glucose value was 389 mg/dl at the time of incident.Customer¿s other blood glucose level was 457 mg/dl, 454 mg/dl and 321 mg/dl.The customer was assisted with troubleshooting.The customer was treated with bolus.Customer was using insulin pump system within 48 hours of reported high blood glucose event.Customer did not mention any symptoms related to high blood glucose event.Customer was not alleging insulin pump was under delivering.Customer reported that they have not contacted their healthcare professional regarding the high blood glucose level.Customer stated that they were not admitted to emergency room, nor hospital or nor to emergency medical service.Customer stated that insulin pump passed the high performance test.Customer stated that the cannula had blood.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: 9557247
• MDR Text Key: 173891812
• Report Number: 3004209178-2020-52210
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169656840
• UDI-Public: (01)00643169656840
• 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: 01/07/2020

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 Model Number: MMT-1715K
• Device Catalogue Number: MMT-1715K
• Device Lot Number: HG1A39R
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/31/2019
• Initial Date FDA Received: 01/07/2020
• Date Device Manufactured: 08/26/2016
• 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-MMT-332,UNOMED SET
• Patient Outcome(s): Other
• Patient Age: 42 YR
• Patient Weight: 58