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 Priming Problem (4040)

Patient Problem Hyperglycemia (1905)

Event Date 03/04/2022

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 reported via phone call that they experienced high blood glucose level.Customer's blood glucose value was 415 mg/dl at the time of the incident.Customer reported insulin pump had insulin flow block alarm.Insulin exited tubing with plunger priming but there was greater than normal resistance when attempting plunger push.Customer was reporting an issue during priming process.Customer stated that they were unable to exit the load reservoir or preparing to prime loop.Customer reported loss of communication between insulin pump and transmitter.Troubleshooting was performed successfully however, the customer will discontinue the use of device.

Manufacturer Narrative

Retainer ring = black.Customer returned insulin pump for alleged prime/fill anomaly, no communication between pump and transmitter and high bg found on (b)(6)2022.Device passed displacement test, self test, rewind test, prime/seating test, basic occlusion test, force sensor test and occlusion test.No unexpected alarms noted during testing.Device successfully downloaded traces and history files using thus.No prime anomaly noted during test.Device properly paired guardian link 3 transmitter.No communication anomaly noted.The electronic assemblies and motor assemblies were inspected, and no anomalies noted.Motor was tested outside of the device and passed the ngp system board test.Force sensor was measured and is within spec (23.3mv at zero offset).Test p-cap / reservoir locks properly into place.No cosmetic damage was found during visual inspection.No communication between pump and transmitter not confirmed during testing.No communication between pump and transmitter not confirmed during testing.Unable to confirm the customer allegation on the high bg.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: 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: 13691603
• MDR Text Key: 286739901
• Report Number: 2032227-2022-121538
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 000000763000316655
• UDI-Public: (01)000000763000316655(17)230515
• 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: 06/28/2022

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: 05/15/2023
• Device Model Number: MMT-1715KL
• Device Catalogue Number: MMT-1715KL
• Device Lot Number: HG4BC06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/04/2022
• Initial Date FDA Received: 03/08/2022
• Supplement Dates Manufacturer Received: 06/20/2022
• Supplement Dates FDA Received: 06/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2020
• 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-332-RSVR, UNOMED INF SET OZO-MMT-7008-SNSR
• Patient Outcome(s): Other
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 155 KG