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 Problem Failure of Device to Self-Test (2937)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/18/2022

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

Information received by medtronic indicated that the insulin pump had a pump error alarm.Customer was assisted with clearing the alarm.Customer was able to successfully clear the alarm.Customer was able to complete insulin pump rewind.Customer stated that they performed displacement test and insulin pump did not pass it.No harm requiring medical intervention was reported.The customer will discontinue use of the device.

Manufacturer Narrative

The pump passed the self test, rewind test, prime/seating test, basic occlusion test, occlusion test, force sensor test, and the displacement test.The pump history and trace files were successfully downloaded using thus.There were no pump error 130 alarms noted during testing.A review of the downloaded history files reveal six (6) pump error 130 alarms (08:32 to 08:57) and five (5) pump error 43 alarms (08:32 to 09:01) that occurred.The pump was cut open to perform visual inspection.Moisture damage was found on the electronic assembly (pcba 1 and pcba 2), motor, and force sensor.Pump error 43 and 130 alarms are not confirmed.No pump error 43 or 130 alarms noted during testing and the alarms in the history file may have been an intermittent failure that was not detected during our testing.A test p-cap does lock into place inside the reservoir compartment properly.The following were noted during physical inspection: scratched case and pillowing keypad overlay.Pump error 43 and pump error 130 alarms are not confirmed.No pump error 43 or pump error 130 alarms noted during testing and the pump error 43 and pump error 130 alarms found in the history file may have been an intermittent failure that was not detected during our testing.Moisture damage is confirmed.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
• 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: 14184067
• MDR Text Key: 293624439
• Report Number: 2032227-2022-182340
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 000000763000316655
• UDI-Public: (01)000000763000316655(17)240921
• 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: 08/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-1715KL
• Device Catalogue Number: MMT-1715KL
• Device Lot Number: HG5QLR7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2021
• 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
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 69 KG