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 Power Problem (3010)

Patient Problems Hypoglycemia (1912); Seizures (2063)

Event Date 08/05/2020

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's wife reported via phone call that the customer woke up with seizures at night and was experiencing low blood glucose levels.The customer declined troubleshooting for low blood glucose level.They also reported that the insulin pump received replace battery alarm without low battery alarm.It was the second occurrence of replace battery now alarm without low battery alarm.The insulin pump will not 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 0.08715 inches.The power management tool confirmed the unloaded voltage and loaded voltage was within spec range.No unexpected battery power loss or replace battery alert/replace battery now alarm noted during testing or in the pump trace download.(b)(4).

Event Description

Caller said customer had a low blood glucose and a seizure on (b)(6) 2020.Sensor glucose value was 80mg/dl but blood glucose was low (in the teens per customer).Customer did not seek medical treatment.Caller said customer did not receive a low battery alert before the other battery alerts/alarms.Customer had an unexpected battery power loss on (b)(6) 2020, which was a second occurrence.Later on customer said she also had a change sensor/calibration not accepted that occurred on (b)(6), 2020 when her blood glucose was 106mg/dl.Per (b)(4), svn 311641721, user had issues with shorter battery life on the transmitter on (b)(6), 2020.Helpline troubleshooted and said charger was working as expected.Customer was going to use a spare charger to see if transmitter will be able to last the life of the sensor.Helpline advised customer to call if issue persists to process a new transmitter.Pump was used at the time of the low bg.Sensor was used.

Manufacturer Narrative

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.Date of event information has been updated and provided with this report in section b3.Information related o the summary has been updated and provided with this report in section b5.

Manufacturer Narrative

This report is part of a retrospective review and remediation efforts in response to a warning letter.Updated h9: 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: 10452627
• MDR Text Key: 204408337
• Report Number: 2032227-2020-168300
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 000000763000190439
• UDI-Public: (01)000000763000190439(17)211107
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/27/2022

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/07/2021
• Device Model Number: MMT-1715K
• Device Catalogue Number: MMT-1715K
• Device Lot Number: HG2YH5P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2020
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/19/2020
• Initial Date FDA Received: 08/26/2020
• Supplement Dates Manufacturer Received: 09/23/2020; 05/16/2022; 10/14/2019
• Supplement Dates FDA Received: 09/24/2020; 05/19/2022; 05/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2018
• 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-MMT-332-RSVR, UNOMED SET; FRN-MMT-332-RSVR, UNOMED SET
• Patient Outcome(s): Other
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Weight: 201 KG