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 Excess Flow or Over-Infusion (1311); Mechanical Problem (1384); No Apparent Adverse Event (3189); Priming Problem (4040)

Patient Problem Hypoglycemia (1912)

Event Date 12/21/2020

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 they were in emergency room for low blood glucose on (b)(6) 2020.Blood glucose reading was 38 mg/dl.The customer was treated with glucagon at the emergency room.Customer current blood glucose was 62 mg/dl and 64 mg/dl.The customer alleges insulin pump was over delivering.Customer stated that insulin was squirting out and insulin pump failed displacement test.The insulin pump and reservoir will be returned for analysis.

Manufacturer Narrative

Device passed the functional tests, including the self test, sleep current measurement, active current measurement, rewind test, prime/seating test, basic occlusion test, occlusion test, force sensor test, displacement test and delivery accuracy test at 0.08720 inches.Device primed and rewinds properly.Device received with pillowing keypad overlay.This mdr related to the puerto rico manufacturing site has been assigned a medwatch number from the medtronic minimed northridge site, per variance 5.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-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
• MDR Report Key: 11074879
• MDR Text Key: 223708835
• Report Number: 2032227-2020-221100
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 000000763000367053
• UDI-Public: (01)000000763000367053(17)230709
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 01/10/2021

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/09/2023
• Device Model Number: MMT-1715KL
• Device Catalogue Number: MMT-1715KL
• Device Lot Number: HG4G4EK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2021
• Initial Date Manufacturer Received: 12/22/2020
• Initial Date FDA Received: 12/28/2020
• Supplement Dates Manufacturer Received: 01/08/2021
• Supplement Dates FDA Received: 01/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNOMED SET, OZO-MMT-7020-SNSR.; UNOMED SET, OZO-MMT-7020-SNSR.
• Patient Outcome(s): Hospitalization
• Patient Age: 70 YR
• Patient Weight: 132