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

Model Number	MMT-523RNAH
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pump passed the rewind, basic occlusion, prime/a33 and displacement test.Pump received with stuck motor error alarm loop during bolus delivery.The motor was tested outside of the device and passed.The motor may have had and intermittent failure that was not detected during our testing.(b)(4).
Event or Problem Description
Information received by medtronic indicated that insulin pump had motor error alarm.Customer was able to successfully clear the alarm and able to rewind the insulin pump.Customer reported that drive support cap was normal and insulin pump had not been exposed to high magnetic field.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-523RNAH
• 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: 10016666
• Report Number: 2032227-2020-112359
• Device Sequence Number: 3158196
• Product Code: OYC
• UDI-Device Identifier: 00643169513068
• UDI-Public: (01)00643169513068
• 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): 05/01/2020

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-523RNAH
• Device Catalogue Number: MMT-523RNAH
• Device Lot Number: A1523RNAHJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2020
• Initial Report FDA Received Date: 05/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 215