MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-751NAB; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number MMT-751NAB

Device Problems Premature Discharge of Battery (1057); Device Difficult to Program or Calibrate (1496); Moisture or Humidity Problem (2986)

Patient Problem Hyperglycemia (1905)

Event Date 08/04/2021

Event Type  malfunction  

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

Information received by medtronic indicated that the insulin pump had button error.Customer stated that they tried taking the battery out of the insulin pump because they could not clear it.Customer stated that the insulin pump also had compromised force sensor system alarm.The customer stated the device was exposed to moisture and they were not able to clear the alarm and rewind the insulin pump.No harm requiring medical intervention was reported.The insulin pump will not be returned for analysis.

Manufacturer Narrative

Customer complaint notes, stated exposure to moisture buttons not responding, button error alarm, menu continues to scroll without input by user.Device received with intermittent button response due to corroded keypad traces.No button error alarm during testing.Perform brush cleaning with the isopropyl alcohol and cleaning up all corrosion and keypad responding properly.Device passed displacement test a21 alarm test and self test.No unexpected a21 alarm anomalies noted.No unexpected number scrolling during testing.However, moisture damage found on the electronics, motor, battery tube and vibrator assembly noted.Device history download using thds was successful.However, a47 alarms found on the history file which caused corrupted data.Unable to confirm the reported event date due to the corrupted data.A47 alarms are due to the insulin pump not having power for a long period of time.Device received with minor scratched lcd window, cracked belt clip slot, cracked battery tube threads, cracked reservoir tube lip and cracked case at the reservoir tube window corners.The test p-cap/reservoir does lock into place.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: 530G INSULIN PUMP MMT-751NAB
• 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: 12323356
• MDR Text Key: 266603991
• Report Number: 2032227-2021-180743
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 000000643169404304
• UDI-Public: (01)000000643169404304
• 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: 12/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-751NAB
• Device Catalogue Number: MMT-751NAB
• Device Lot Number: A2751NABJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/05/2021
• Initial Date FDA Received: 08/16/2021
• Supplement Dates Manufacturer Received: 12/04/2021
• Supplement Dates FDA Received: 12/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2013
• 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 Age: 59 YR
• Patient Sex: Male
• Patient Weight: 88 KG