MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723LNAL; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-723LNAL
Medical Device Problem Codes	Mechanical Problem (1384); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Information received by medtronic indicated that the insulin pump had a motor error alarm.Customer also reported no delivery.Customer was able to clear the alarm and rewind the insulin pump.No harm requiring medical intervention was reported.The customer will discontinue to use the device.
Additional Manufacturer Narrative
Sw 2.5b.On the event date (b)(6) 2019.Customer returned pump for an alleged issue with no delivery alarm and motor error.Pump passed a21 error test, seat, rewind and basic occlusion test, occlusion test, prime/a33 test, excessive no delivery test and displacement test.No delivery alarm and no motor error alarm during testing.Pump history download using thds was successful.Unable to confirm reported event date & time and to verify whether alarm occurred during basal or bolus due to a47 alarms found on the history file which caused corrupted data.A47 alarms are due to the pump not having power for a long period of time.Unit was cut/open and inspected no moisture damage or component damage found inside the pump.The test p-cap/reservoir does lock into place.Motor passed motor test.The following were noted during visual inspection: cracked reservoir tube lip.Pump passed all required testing.No unexpected no delivery alarm and motor error alarm during testing.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: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723LNAL
• Common Device Name: PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386; * 00777-3869
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386; * 00777-3869
• Manufacturer Contact: tricha miles ; ceiba norte ind. park #50 road; juncos 00777--386 ; * 00777-3869 ; 7635140379
• MDR Report Key: 14043027
• Report Number: 2032227-2022-176888
• Device Sequence Number: 2239406
• Product Code: OYC
• UDI-Device Identifier: 00643169478589
• UDI-Public: (01)00643169478589
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/07/2022

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
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-723LNAL
• Device Catalogue Number: MMT-723LNAL
• Device Lot Number: A4723LNALJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2019
• Initial Report FDA Received Date: 04/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 168