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

Model Number	MMT-723NAS
Medical Device Problem Codes	Device Difficult to Program or Calibrate (1496); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	05/26/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
The customer reported via phone call that they were hospitalized due to hyperglycemia and passed out on (b)(6) 2020.The customer¿s blood glucose level was unknown at time of incident.The customer was assisted with troubleshooting.The customer experienced food poison or infection.The customer was treated with strong antibiotics or intravenous fluid.The insulin pump buttons were not responding after replacing battery.The device will be returned for analysis.
Additional Manufacturer Narrative
Device passed the displacement test, rewind, self test and a21 error test.All operating currents are within specification.Off no power alarm functions properly.Device was unable to prime during prime/a33 test and alarmed motor error during basic occlusion test due to faulty force sensor resistor.The motor was tested outside of the unit and passed.Unable to perform the occlusion test, excessive no delivery test and the delivery accuracy test due to prime anomaly.Device had intermittent button response on the esc and act buttons due to corroded keypad traces.No button error alarm noted.During visual inspection, the j2 keypad connector on the lcd/b was found locked properly.Device uploaded properly using carelink.Device had cracked battery tube threads, scratched reservoir tube window and cracked reservoir tube lip.The test p-cap and reservoir does lock in place in the reservoir compartment.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAS
• 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
• MDR Report Key: 10126313
• Report Number: 2032227-2020-126919
• Device Sequence Number: 2341973
• Product Code: OYC
• UDI-Device Identifier: 00643169202399
• UDI-Public: (01)00643169202399
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Followup
• Report Date (Section B): 07/08/2020

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-723NAS
• Device Catalogue Number: MMT-723NAS
• Device Lot Number: A8723NASJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2020
• Initial Date Received by Manufacturer: 05/30/2020
• Supplement Date Received by Manufacturer: 07/07/2020
• Initial Report FDA Received Date: 06/06/2020
• Supplement Report FDA Received Date: 07/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 54 YR
• Patient Weight: 93