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

Model Number	MMT-723RNAP
Medical Device Problem Codes	Device Difficult to Program or Calibrate (1496); Detachment of Device or Device Component (2907); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	10/28/2018
Type of Reportable Event	Malfunction
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
Customer reported via phone call that insulin pump buttons were not working and drive support cap was flush.Customer¿s high blood glucose was 271 mg/dl at the time of incident.The customer was treated with syringe.The customer stated that battery compartment was clack.Troubleshooting was performed.The customer stated that insulin pump had keypad issue.Advised the pump will need to be replaced.Advised to discontinue use of the pump and revert to a back-up plan.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Device received with broken battery tube thread noted.Device passed displacement test, rewind test, basic occlusion test, prime/a33 test, excessive no delivery test and occlusion test.All buttons functioning properly.No button error alarm during testing.No moisture or corroded keypad found.No flatted keypad.Connector was inspected and locked on lcd board.Pump passed self test.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723RNAP
• 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: 9265309
• Report Number: 2032227-2019-112226
• Device Sequence Number: 19486749
• Product Code: OYC
• UDI-Device Identifier: 00643169476660
• UDI-Public: (01)00643169476660
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): 01/23/2020

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-723RNAP
• Device Catalogue Number: MMT-723RNAP
• Device Lot Number: A0723RNAPJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2019
• Initial Date Received by Manufacturer: 10/29/2019
• Supplement Date Received by Manufacturer: 01/22/2020
• Initial Report FDA Received Date: 11/01/2019
• Supplement Report FDA Received Date: 01/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Weight: 102