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

Model Number	MMT-723RNAB
Medical Device Problem Codes	Device Difficult to Program or Calibrate (1496); Battery Problem (2885); Loss of Data (2903)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	07/01/2019
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 buttons of insulin pump were hard to press.The customer¿s blood glucose level was unknown at the time of the incident.Customer also stated that insulin pump had pump error alarm and customer was able to clear the alarm and able to complete rewind.Customer was advised to discontinue use of the insulin pump and revert to back up plan per health care professional.The insulin pump will be returned for analysis.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723RNAB
• 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: 9254128
• Report Number: 2032227-2019-110815
• Device Sequence Number: 3934759
• Product Code: OYC
• UDI-Device Identifier: 00643169476561
• UDI-Public: (01)00643169476561
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 10/29/2019

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-723RNAB
• Device Catalogue Number: MMT-723RNAB
• Device Lot Number: A0723RNABJ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2019
• Initial Report FDA Received Date: 10/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 172