MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523RNAS; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-523RNAS
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Pump received with reservoir tube lip completely broken off noted.The test reservoir does not stay locked in place due to reservoir tube lip broken off.Unable to perform displacement test due to reservoir lip broken.
Event or Problem Description
Information received by medtronic indicated that the insulin pump was damaged no harm requiring medical intervention was reported.The insulin pump will was return for analysis and found the pump received with reservoir tube lip completely broken off noted.The test reservoir does not stay locked in place due to reservoir tube lip broken off.Unable to perform displacement test due to reservoir lip broken.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523RNAS
• 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: 10060210
• Report Number: 2032227-2020-118161
• Device Sequence Number: 11362890
• Product Code: OYC
• UDI-Device Identifier: 00643169221550
• UDI-Public: (01)00643169221550
• Combination Product (Y/N): N
• 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): 05/14/2020

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-523RNAS
• Device Catalogue Number: MMT-523RNAS
• Device Lot Number: A000290041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2020
• Initial Report FDA Received Date: 05/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 95