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 Problem Break (1069)

Patient Problems Fatigue (1849); Hyperglycemia (1905)

Event Date 12/16/2021

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 experienced high blood glucose.Customer's current blood glucose value was 494 mg/dl.The customer experienced symptoms related to high blood glucose such as fatigue.The customer was not using the auto mode feature at the time of high blood glucose event.The customer also reported that the insulin pump had a cracked retainer ring and battery compartment.The reservoir was able to lock into place.The insulin pump will be returned for analysis.

Manufacturer Narrative

Retainer = black.Device was returned for an unexpected no delivery alarms on event date 12/16/2021.Unable to perform the displacement test and self-test due to unresponsive keypad.No damage in the keypad assembly noted.However, j1 connector on pcba 1 was inspected and found corroded keypad flex cable.Device passed the keypad voltage test.Unable to download files using thus software due to unresponsive keypad.No physical damage noted during visual inspection.The following were noted during visual inspection cracked battery tube threads, cracked battery tube threads and cracked case at battery tube side.Unresponsive keypad was confirmed due to corroded keypad flex cable.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: tricha miles ; ceiba norte ind. park #50 road; juncos 00777--386 ; 7635140379
• MDR Report Key: 13051018
• MDR Text Key: 282545953
• Report Number: 2032227-2021-233034
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 000000763000316631
• UDI-Public: (01)000000763000316631
• 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
• Report Date: 05/19/2022

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 Model Number: MMT-1715K
• Device Catalogue Number: MMT-1715K
• Device Lot Number: HG4PT4Z
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/16/2021
• Initial Date FDA Received: 12/21/2021
• Supplement Dates Manufacturer Received: 05/18/2022
• Supplement Dates FDA Received: 05/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2020
• 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: FRN-UNK-RSVR, UNOMED SET
• Patient Outcome(s): Other
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 94 KG