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 Break (1069); Connection Problem (2900)

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

Event Date 03/28/2021

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 hospitalized for diabetic ketoacidosis and passed out on unknown date. Blood glucose reading was unknown. The customer was treated with intravenous insulin drip and manual injection at the hospital. Customer current blood glucose was 128 mg/dl. The customer stated that insulin pump retainer ring came off and reservoir was not able to lock in place. The insulin pump will be returned for analysis.

Manufacturer Narrative

Device was received with scratched case, missing retainer, cracked select button keypad overlay, stained keypad overlay, keypad overlay texture damage, missing reservoir tube o-ring, and pillowing keypad overlay. A test p-cap and reservoir was installed and did not lock in place due to missing retainer. Device passed the rewind test, prime or seating test, basic occlusion test, force sensor test, self test, sleep current measurement, and active current measurement however, unable to perform the displacement test, occlusion test, and delivery accuracy test due to missing retainer.

Event Description

It was reported that the customer was hospitalized for diabetic ketoacidosis and passed out on (b)(6) 2021.

• 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: tricha miles ; ceiba norte ind. park #50 road; juncos 00777--386 ; 7635140379
• MDR Report Key: 11639737
• MDR Text Key: 244604512
• Report Number: 2032227-2021-133399
• 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

• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 02/18/2022
• Device Model Number: MMT-1715KL
• Device Catalogue Number: MMT-1715KL
• Device Lot Number: HG36LZW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown
• Removal/Correction Number: Z-0955-2020

Patient Treatment Data

Date Received: 04/09/2021 Patient Sequence Number: 1

Treatment

FRN-UNK-RSVR, UNOMED SET.