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-1715KL

Device Problems Excess Flow or Over-Infusion (1311); Patient Device Interaction Problem (4001)

Patient Problems Hypoglycemia (1912); Seizures (2063); Vomiting (2144); Diabetic Ketoacidosis (2364); Coma (2417); Loss of consciousness (2418)

Event Date 08/19/2020

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.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 had hypoglycemia and emergency medical service dispatched him to the hospital on (b)(6) 2020 with blood glucose of 28 mg/dl.Customer wanted to report a problem with the insulin pump, it gave him too much insulin.Customer's fiance called him on tuesday but she cannot reach him so she called the police and found customer was unresponsive and ambulance personnel treated him with glucose at home.Customer called to report that the he was in coma since there was something on his insulin pump and when he checked his mail box he noticed the safety notice and check that the insulin pump reservoir retainer ring was broken.Customer stated that his low blood glucose was due to insulin pump's issue.Customer reported that his low blood glucose value resulted in coma, diabetic ketoacidosis, loss of consciousness and seizure.Customer had to stay in hospital overnight due to low blood glucose.The customer received treatment with insulin infusion drip, treatment with glucagon, insulin injection administered by health care professional.Customer was treated by ambulance at home with glucose, and made him throw up.Customer reported that the reservoir was showing same amount of insulin as showed on status screen.Troubleshooting was performed for the low blood glucose and cosmetic damage.Customer mentioned that the reservoir was able to lock in place.Insulin pump will be returned for analysis.

Manufacturer Narrative

The material number, serial number and lot number has been updated and provided with this report.(b)(4).

Event Description

The material number has updated to mmt-1715kl, serial number to (b)(4) and lot number to hg4kjlf.

Manufacturer Narrative

The information that provided with the initial report was incorrect.The correct information has been included with this report.(b)(4).

Event Description

It was reported that the customer had a low blood glucose of 28 mg/dl and was found unresponsive on (b)(6) 20020.He required the assistance of emergency medical services.Customer reported damage to the insulin pump, with a crack on the retainer ring.The reservoir locks into place.Customer alleges over delivery.Troubleshooting was performed for the low blood glucose and damage.Insulin pump will 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: 10452508
• MDR Text Key: 204335645
• Report Number: 2032227-2020-168227
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 000000763000190439
• UDI-Public: (01)000000763000190439(17)211118
• 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,Followup,Followup
• Report Date: 12/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/18/2021
• Device Model Number: MMT-1715KL
• Device Catalogue Number: MMT-1715K
• Device Lot Number: HG4KJLF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/07/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2018
• 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: UNOMED SET,
• Patient Outcome(s): Hospitalization
• Patient Age: 50 YR
• Patient Weight: 99