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 Problem Break (1069)

Patient Problems Hyperglycemia (1905); Diabetic Ketoacidosis (2364); Loss of consciousness (2418)

Event Date 03/19/2022

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 they were dispatched through medical emergency services and hospitalized due to high blood glucose and diabetic ketoacidosis on (b)(6) 2022. The customer¿s blood glucose level was 880 mg/dl at the time of incident. The customer¿s current blood glucose value was 286 mg/dl. The customer passed out due to high blood glucose. The customer treated high blood glucose with insulin drip. Customer had been using insulin pump system within 48 hours of reported high blood glucose event. Customer stated that the insulin pump had physical damage. No further patient complications were reported. Troubleshooting was performed; however, the customer will discontinue use of the device.

• 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: tricha miles ; ceiba norte ind. park #50 road; juncos 00777--386 ; 00777-3869 ; 7635140379
• MDR Report Key: 13895882
• MDR Text Key: 288516822
• Report Number: 2032227-2022-171457
• 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: 03/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: MMT-1715KM
• Device Catalogue Number: MMT-1715KM
• Device Lot Number: HG1TKMR
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/21/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 04/27/2017
• 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: 03/24/2022 Patient Sequence Number: 1

Treatment

FRN-UNK-RSVR, UNOMED INF SET