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 Excess Flow or Over-Infusion (1311)

Patient Problem Hypoglycemia (1912)

Event Date 06/15/2022

Event Type  Injury  

Event Description

Customer reported via phone call that they experienced low blood glucose level.Customer's blood glucose value was 50 mg/dl at the time of the incident.Customer's current blood glucose level was 114 mg/dl.The customer was assisted with troubleshooting for low blood glucose.The customer was treated with food.Customer had been using insulin pump system within 48 hours of reported low blood glucose event.Customer stated that the auto mode feature was not active at time of low blood glucose event.Customer stated that the settings were same and the blood glucose level was 125 mg/dl.Customer eat and leave the insulin pump on for 30 minutes and the blood glucose level goes down to 50 mg/dl.No further patient complications were reported.The device will be returned for analysis.

Manufacturer Narrative

(b)(4).Currently it is unknown whether or not the device may have caused or contributed to the event.The device has been returned, but not yet evaluated.Further information will follow once the analysis has been completed.No conclusion can be drawn at this time.

Manufacturer Narrative

The pump passed the displacement test, the rewind test, prime/seating test, basic occlusion test, force sensor test, occlusion test, and self test.The pump passed displacement accuracy test at 0.0872 inches.Test p-cap and reservoir locks properly into the reservoir compartment.No unexpected alerts, alarms, or anomalies noted during testing.Pump's history and trace files downloaded successfully using thus software and carelink and generated reports.In the pump history and trace files found bolus deliveries on the event date of (b)(6) 2022 at 08:20:00.000, 12:44:00.000, 17:22:00.000, 17:39:46.000, 19:50:22.000, 20:42:04.000, and 22:07:28.000.No alerts, alarms, or anomalies were found in the pump history files and traces on the event date.Pump was cut open to perform visual inspection and found no evidence of physical or moisture damage on the electronic assembly, motor, and force sensor.The following were noted during visual inspection: scratched case, and pillowing keypad overlay.Possible over delivery anomaly was not confirmed during testing.Unable to verify customer's complaint for low bg's.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: 15061741
• MDR Text Key: 296208192
• Report Number: 2032227-2022-293515
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 000000763000316655
• UDI-Public: (01)000000763000316655(17)240902
• 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: 09/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2022
• Is this an Adverse Event Report?: Yes
• 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: HG5ND4Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/03/2021
• 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
• Treatment: FRN-MMT-332-RSVR, UNOMED INF SET
• Patient Outcome(s): Other
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 66 KG