MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723RNAL; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-723RNAL
Medical Device Problem Codes	Premature Discharge of Battery (1057); Power Problem (3010); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Unit received with all operating currents within spec and passed self-test and displacement test.No unexpected low battery, weak batt, battery out limit, a17 or failed batt test alarms noted during testing.However, unit alarmed a21 after battery change and resets time/date to factory default due to c13 voltage leak at interface board.
Event or Problem Description
Customer reported via phone call that the insulin pump had pump error signal too low alarm and no delivery/occlusion alarm during therapy.Customer blood glucose level was 200 mg/dl.Customer also stated that the they were able to clear the alarm and able to rewind the insulin pump.The device will be returned for analysis.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723RNAL
• Common Device Name: PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• MDR Report Key: 8338111
• Report Number: 2032227-2019-01441
• Device Sequence Number: 1554839
• Product Code: OYC
• UDI-Device Identifier: 00613994748737
• UDI-Public: (01)00613994748737
• 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): 02/13/2019

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-723RNAL
• Device Catalogue Number: MMT-723RNAL
• Device Lot Number: A000168688
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2019
• Initial Report FDA Received Date: 02/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 89 YR
• Patient Weight: 215