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 Problems Premature Discharge of Battery (1057); Break (1069); Device Displays Incorrect Message (2591)

Patient Problems Aneurysm (1708); Hyperglycemia (1905); Hypoglycemia (1912); Loss of consciousness (2418)

Event Date 03/07/2018

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

Customer called and reported that they received emergency medical assistance and got hospitalized due to low blood glucose on (b)(6) 2018 with blood glucose of around 70 mg/dl at the time of the incident.The customer was at 166 mg/dl at the time of hospitalization.The customer used food and was given intravenous fluids to treat.The customer experienced symptoms such as loss of consciousness.The customer found out they have an aneurysm in their heart.The customer was wearing the insulin pump during the incident.Troubleshooting was not completed as the customer declined.The customer reported shortened battery life and a damaged battery cap.The customer also got multiple power loss alarms while the battery was in the pump.The insulin pump will be returned for analysis.

Manufacturer Narrative

Device passed the self test, sleep current measurement, active current measurement, rewind test, prime test, basic occlusion test and force sensor test.However, device unable to perform the displacement test, displacement accuracy test and occlusion test due to missing retainer and reservoir tube o-ring.Device received with normal operating currents.No unexpected replace battery alert, replace battery now alarm or power loss alarm.Unable to verify battery cap damage due to pump received without the original battery cap.The information provided in the section of concomitant product with the initial report was incorrect.The correct information has been included with this report.

Manufacturer Narrative

The information provided in the initial report was incorrect.The correct information has been included with this report.

Event Description

It was reported that the customer declined troubleshooting for high blood glucose.Harm code has been updated in aneurysm and low blood glucose and high blood glucose.

Manufacturer Narrative

This report is part of a retrospective review and remediation efforts in response to a warning letter.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.

Manufacturer Narrative

Updated h9: 2032227-060322-002-c.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: 8034047
• MDR Text Key: 125985443
• Report Number: 2032227-2018-55029
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169656840
• UDI-Public: (01)00643169656840
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-1715K
• Device Catalogue Number: MMT-1715K
• Device Lot Number: HG1A927
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: 2032227-060322-002-C
• Patient Sequence Number: 1
• Treatment: FRN-UNK-RSVR UNOMED SET; UNO INF SETFRN RESERVOIR; FRN-UNK-RSVR UNOMED SET
• Patient Outcome(s): Hospitalization
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 316 KG