MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722NAB; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-722NAB
Medical Device Problem Codes	Device Difficult to Program or Calibrate (1496); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Hyperglycemia (1905); Elevated ketones/Diabetic Ketoacidosis (2364)
Date of Event	03/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 or Problem Description
The customer reported via phone call that the customer was hospitalized due to hyperglycemia and diabetic ketoacidosis on (b)(6) 2019 with an unknown blood glucose value.The customer was assisted with troubleshooting.The customer was treated with insulin drip during hospitalization.Customer stated that the insulin pump had button error.Customer also stated that they were unable to clear the alarm.The customer reported that the esc and act buttons are not responding.Customer stated that they were removed from the insulin pump when went to the hospital for a separate reason and ended up having high blood glucose values and diabetic ketoacidosis while in the hospital.Customer declined to perform a carelink upload.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Device passed the functional test, including the displacement test, rewind, basic occlusion test, occlusion test, prime test, excessive no delivery test and delivery accuracy test at 0.08740 inches.The stop current and run current measurement tests are within specification.Device also passed self test, off no power alarm test and unexpected restart error test.Device uploaded properly using carelink.Device had intermittent button response on the express bolus, esc and act buttons due to corroded keypad traces.No button error alarm noted during testing.Device had minor scratched display window, cracked case at display window corner, cracked battery tube threads, cracked reservoir tube lip and a missing end cap sticker.
Additional Manufacturer Narrative
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.The initial report was submitted with missing information.The information had been updated and provided with this report in section b5.Component code has been updated and provided with this report in section h6.Occupation has been updated and provided with this report in section e3.Health effect ¿ impact code has been updated and provided with this report in section h6.
Event or Problem Description
The device was returned for analysis.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722NAB
• 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
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386
• Manufacturer Contact: gerwin de graaff ; ceiba norte ind. park #50 road; juncos 00777--386 ; 8185464805
• MDR Report Key: 8419630
• Report Number: 3004209178-2019-67604
• Device Sequence Number: 2170840
• Product Code: OYC
• UDI-Device Identifier: 00613994622594
• UDI-Public: (01)00613994622594
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/16/2023

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
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-722NAB
• Device Catalogue Number: MMT-722NAB
• Device Lot Number: B2722NABJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2019
• Initial Date Received by Manufacturer: 03/08/2019
• Supplement Date Received by Manufacturer: 05/20/2019; 01/12/2023
• Initial Report FDA Received Date: 03/14/2019
• Supplement Report FDA Received Date: 05/27/2019; 01/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2014
• 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
• Concomitant Medical Products and Therapy/Usage Dates: FRN-UNK-RSVR, UNOMED INF SET.; FRN-UNK-RSVR, UNOMED INF SET
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 28 YR
• Patient Sex: Male
• Patient Weight: 74 KG