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 Codes	Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/26/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Unit passed the displacement test, self test, off no power test, rewind test, basic occlusion test and prime/a33 test.The operating currents were within specification.Unit received with stuck motor error alarm loop during bolus/basal delivery.Unable to verify excessive no delivery alarm due to motor error alarm.The motor may have had an intermittent failure that was not detected during our testing.The motor was tested outside of the unit and passed.Unable to perform a21 error test, occlusion test, excessive no delivery test and dat test due to motor error alarms.The test p-cap and reservoir does lock in place in the reservoir compartment.
Event or Problem Description
Information received by medtronic indicated that the insulin pump had motor error alarm.Customer was able to complete rewind.Customer reported that the drive support cap appeared to be normal.No harm requiring medical intervention was reported.The device 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: 10044093
• Report Number: 2032227-2020-116473
• Device Sequence Number: 3792012
• Product Code: OYC
• UDI-Device Identifier: 00613994743848
• UDI-Public: (01)00613994743848
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/11/2020

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-523NAB
• Device Catalogue Number: MMT-523NAB
• Device Lot Number: A3523NABJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2020
• Initial Report FDA Received Date: 05/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 13 YR