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 Problems Break (1069); Connection Problem (2900)

Patient Problems Hyperglycemia (1905); Diabetic Ketoacidosis (2364); Loss of consciousness (2418)

Event Date 03/28/2021

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 were hospitalized for diabetic ketoacidosis and passed out on unknown date.Blood glucose reading was unknown.The customer was treated with intravenous insulin drip and manual injection at the hospital.Customer current blood glucose was 128 mg/dl.The customer stated that insulin pump retainer ring came off and reservoir was not able to lock in place.The insulin pump will be returned for analysis.

Manufacturer Narrative

Device was received with scratched case, missing retainer, cracked select button keypad overlay, stained keypad overlay, keypad overlay texture damage, missing reservoir tube o-ring, and pillowing keypad overlay.A test p-cap and reservoir was installed and did not lock in place due to missing retainer.Device passed the rewind test, prime or seating test, basic occlusion test, force sensor test, self test, sleep current measurement, and active current measurement however, unable to perform the displacement test, occlusion test, and delivery accuracy test due to missing retainer.

Event Description

It was reported that the customer was hospitalized for diabetic ketoacidosis and passed out on (b)(6) 2021.

Manufacturer Narrative

Retainer ring = missing.On (b)(6) 2021 the customer alleged was hospitalized for high blood glucoses and diabetic ketoacidosis.In addition, customer alleged cosmetic damage located at the back of the insulin pump and retainer ring.Successfully downloaded history files and traces using thus.Successfully uploaded to carelink and generated reports.The insulin pump was received with scratched case, missing retainer, cracked select button keypad overlay, stained keypad overlay, keypad overlay texture damage, missing reservoir tube o-ring, and pillowing keypad overlay.A test p-cap and reservoir was installed and did not lock in place due to missing retainer.The pump passed the rewind test, prime/seating test, basic occlusion test, force sensor test, self test, sleep current measurement, and active current measurement however, unable to perform the displacement test, occlusion test, and delivery accuracy test due to missing retainer.Cosmetic damage was confirmed where scratched case, missing retainer, and missing reservoir tube o-ring was noted.Unable to fully test insulin pump due to missing retainer.Unable to verify customer complaint for high blood glucoses and diabetic ketoacidosis.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

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-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: 11639737
• MDR Text Key: 244604512
• Report Number: 2032227-2021-133399
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 000000763000166519
• UDI-Public: (01)000000763000166519(17)220218
• 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: 04/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/18/2022
• Device Model Number: MMT-1715KL
• Device Catalogue Number: MMT-1715KL
• Device Lot Number: HG36LZW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2019
• 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-UNK-RSVR, UNOMED SET.; FRN-UNK-RSVR, UNOMED SET.
• Patient Outcome(s): Hospitalization
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Weight: 61 KG