MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523NAB; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-523NAB
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	01/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Unit passed basic occlusion test and displacement test.No motor error alarms were noted.However, unable to prime unit during prime/a33 test due to encoder signal out of phase.Unable to perform occlusion test and excessive no delivery test due to prime anomaly.The motor was tested outside the device and passed.(b)(4).
Event or Problem Description
Information received by medtronic indicated that the insulin pump had a motor error alarm.The customer stated they were able to clear the alarm and were able to complete the rewind process.Customer stated that the screen was flashed and then stopped.Customer reported that the alarm did not appear on the screen.Customer received recurring motor error alarm.No harm requiring medical intervention was reported.The insulin pump will be returned for analysis.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523NAB
• 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; * 00777-3869
• MDR Report Key: 12055376
• Report Number: 2032227-2021-160541
• Device Sequence Number: 19836938
• Product Code: OYC
• UDI-Device Identifier: 00643169507166
• UDI-Public: (01)00643169507166
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/23/2021

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-523NAB
• Device Catalogue Number: MMT-523NAB
• Device Lot Number: B4523NABJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2018
• Initial Report FDA Received Date: 06/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1