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 12/21/2021

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.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.

Event Description

The customer reported via phone call that the emergency medical service was dispatched for low blood glucose.Blood glucose reading was 42 mg/dl at the time of incident.The customer stated they felt dizzy from their low blood glucose.The low event was caused by the customer forgetting to eat.It was alleged that the insulin pump have over delivered.Troubleshooting for the customer¿s low blood glucose was declined.The insulin pump will not be returned for analysis.

Manufacturer Narrative

Retainer ring = black.Customer returned insulin pump for an alleged possible over delivery and ems dispatched for low blood glucoses found on (b)(6) 2021.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 0.08695 inches.Successfully downloaded history files and traces using thus.Successfully uploaded pump to carelink.In further full review of the pump history/traces on the event date on (b)(6)2021, there is no unexpected alarms/suspends and found bolus wizard deliveries of daily total of bolus insulin delivered = 11.5 u bolus.On (b)(6) 2021 08:49:58.000.Normal bolus delivered normal bolus amount programmed = 1.3 bolus amount delivered = 1.3 on (b)(6) 2021 11:27:02.000.Normal bolus delivered normal bolus amount programmed = 1.4 bolus amount delivered = 1.4 on (b)(6) 2021 12:19:02.000.Dual bolus part delivered normal bolus amount programmed = 1 square bolus amount programmed = 1.1 bolus amount delivered = 1.On (b)(6) 2021 12:49:00.000.Dual bolus part delivered normal bolus amount programmed = 1 square bolus amount programmed = 1.1 bolus amount delivered = 1.1.On (b)(6) 2021 17:00:10.000.Normal bolus delivered, normal bolus amount programmed = 1.8.Bolus amount delivered = 1.8 on (b)(6) 2021 18:07:16.000 normal bolus delivered normal bolus amount programmed = 1.5 bolus amount delivered = 1.5 on (b)(6) 2021 18:47:08.000.Normal bolus delivered normal bolus amount programmed = 0.7 bolus amount delivered = 0.7 on (b)(6) 2021 19:42:36.000.Normal bolus delivered normal bolus amount programmed = 2.3 bolus amount delivered = 2.3 on (b)(6) 2021 23:05:38.000 normal bolus delivered normal bolus amount programmed = 0.4 bolus amount delivered = 0.4.Device was programmed with multiple bolus deliveries and all bolus delivered properly their indicated amounts (at quick bolus speed) and were properly recorded in the daily history.No bolus delivery anomaly or history anomaly noted.No under delivery anomaly or over delivery anomaly noted during testing.Test p-cap and reservoir locked properly into reservoir compartment during testing.The following were noted during visual inspection: a scratched case.Device passed all the required testing.Unable to verify customer alleged for low blood glucoses.Customer alleged for possible over delivery was not confirmed.(b)(4).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: 13091203
• MDR Text Key: 282813113
• Report Number: 2032227-2021-235577
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 000000763000367053
• UDI-Public: (01)000000763000367053(17)240714
• 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: 03/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-1715KL
• Device Catalogue Number: MMT-1715KL
• Device Lot Number: HG5H3Z7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2021
• 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-332A-RSVR, UNK-UNOMED-INF-SET.
• Patient Outcome(s): Hospitalization
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 58 KG