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 Insufficient Flow or Under Infusion (2182); No Apparent Adverse Event (3189); Patient Device Interaction Problem (4001)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912); Swelling (2091)

Event Date 07/01/2019

Event Type  malfunction  

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 the insulin pump was alleging possible pump under delivery the customer blood glucose level was 326 mg/dl at the time of incident and the current blood glucose level was unknown.The customer was offered to troubleshooting for low blood glucose as well as high blood glucose.The customer was treated with bolus for high blood glucose.Customer was using insulin pump system within 48 hours of reported high blood glucose event.Customer reports they did not contact their health care professional regarding the high blood glucose.Customer was performed displacement test and they did the massage no reservoir, on the pump screen.The customer stated that the insulin pump was broken at the top of reservoir lip ring.Customer stated that reservoir able to lock in the place when inserted into the insulin pump.The insulin pump will be returned for analysis.

Manufacturer Narrative

Device passed the self test, sleep current measurement, active current measurement, rewind test, prime or seating test, basic occlusion test and force sensor test.The test reservoir does not lock in place and unable to perform the displacement test, displacement accuracy test and occlusion test due to missing retainer and missing reservoir tube o-ring.Device received with scratched case, pillowing keypad overlay, cracked case behind the device at the battery compartment, cracked select button keypad overlay and minor scratched lcd window.

Manufacturer Narrative

This report is part of a retrospective review and remediation efforts in response to a warning letter.Z-0955-2020.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.Medtronic objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.

• 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: 8920448
• MDR Text Key: 155188773
• Report Number: 2032227-2019-51259
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169656840
• UDI-Public: (01)00643169656840(17)180302
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 05/21/2022

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/02/2018
• Device Model Number: MMT-1715K
• Device Catalogue Number: MMT-1715K
• Device Lot Number: HG19X3W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2019
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/09/2019
• Initial Date FDA Received: 08/22/2019
• Supplement Dates Manufacturer Received: 10/09/2019; 10/14/2019
• Supplement Dates FDA Received: 10/15/2019; 05/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: Z-0955-2020
• Patient Sequence Number: 1
• Treatment: FRN-UNK-RSVR, UNOMED INF SET; FRN-UNK-RSVR, UNOMED INF SET
• Patient Outcome(s): Hospitalization
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 102 KG