MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PUMP MMT-1715KM 630G 3ML BLACK MEDI ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number MMT-1715KM

Device Problems Insufficient Flow or Under Infusion (2182); No Apparent Adverse Event (3189)

Patient Problems Fatigue (1849); Hyperglycemia (1905); Hypoglycemia (1912); Weakness (2145); Anxiety (2328); Sweating (2444); Shaking/Tremors (2515); Confusion/ Disorientation (2553)

Event Date 07/10/2020

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. 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 they experienced high and low blood glucose. The customer¿s blood glucose level was 226 mg/dl and 40 mg/dl which was treated with manual injection for high blood glucose and food for low blood glucose. Customer was experienced symptoms like shaking, sweating, anxiety, mental confusion, inability to follow simple commands, weakness and fatigue. Customer was performed self and displacement test and it was pass. The customer also stated that they did allege insulin pump was under delivering. Customer had been using insulin pump system within 48 hours of reported high blood glucose event. Customer was neither in emergency room nor admitted into hospital. Customer stated that auto mode feature was not active. The insulin pump and reservoir will not be returned for analysis.

• Brand Name: PUMP MMT-1715KM 630G 3ML BLACK MEDI
• 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: 10308194
• MDR Text Key: 199870012
• Report Number: 2032227-2020-150868
• 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: 07/22/2020

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 07/22/2020
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: Yes
• Device Operator: LAY USER/PATIENT
• Device MODEL Number: MMT-1715KM
• Device Catalogue Number: MMT-1715KM
• Device LOT Number: HG1KX9Q
• 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: 07/16/2020
• Was Device Evaluated By Manufacturer?: No Answer Provided
• Date Device Manufactured: 01/03/2017
• 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: 07/22/2020 Patient Sequence Number: 1

Treatment

UNOMED INF SET