MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PUMP MMT-1714K 630G BLACK MMOL CANADA; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number MMT-1714K

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912)

Event Date 11/22/2021

Event Type  Injury  

Event Description

It was reported that the customer were experienced low blood glucose.Blood glucose level at the time of the incident was 2 mmol/l treated with food.Customer alleged insulin pump was over delivering because high and low blood glucose event was occurred at random times.Customer had been using the insulin pump system within 48 hours of reported low blood glucose event.Customers last blood glucose reading was 11 mmol/l.The insulin pump will not 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 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.

Manufacturer Narrative

Retainer ring = clear.Customer returned pump for alleged over delivery, high bg, and low bg found on 22-nov-2021.Pump passed the self test, displacement test, rewind test, prime/seating test, basic occlusion test, force sensor test, occlusion test, and dat at.0873 inches.No unexpected alarms/alert/anomalies noted during testing.The history/trace downloads were successful using thus and carelink.The following boluses were delivered on event date: dailytotalofbolusinsulindelivered = 22.5.Totalmanualbolusinsulindelivered = 22.5.Test p-cap and reservoir locked properly into reservoir compartment during testing.Pump was cut open to perform visual inspection and found no evidence of physical or moisture damage on the electronic assembly, motor, or force sensor.The following were noted during visual inspection: battery tube threads - cracked, stained keypad overlay, cracked case-corner of belt clip rails, pillowing keypad overlay, and cracked retainer.Pump passes function testing.Unable to verify customer alleged for high bg, low bg, and possible over delivery anomaly.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.

• Brand Name: PUMP MMT-1714K 630G BLACK MMOL CANADA
• 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: 12916125
• MDR Text Key: 281591824
• Report Number: 2032227-2021-225836
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 000000643169782396
• UDI-Public: (01)000000643169782396
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-1714K
• Device Catalogue Number: MMT-1714K
• Device Lot Number: HG22UW2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 10/18/2017
• 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
• Patient Outcome(s): Other