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

Model Number	MMT-523RNAL
Medical Device Problem Codes	Moisture or Humidity Problem (2986); Power Problem (3010)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Insulin pump received with blank display due to moisture damage at electronic assembly.Also, moisture damage motor during visual inspection.Unable to perform operating currents, self test, rewind test and displacement test or verify failed battery test due to blank display.
Event or Problem Description
Information received by medtronic indicated that the insulin pump had failed battery test.Insulin pump was exposed to fluid, it was fell into water.Self test was passed.No harm requiring medical intervention was reported.The insulin pump will not be returned for analysis.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523RNAL
• 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: 10274516
• Report Number: 2032227-2020-146525
• Device Sequence Number: 11416410
• Product Code: OYC
• UDI-Device Identifier: 00643169476486
• UDI-Public: (01)00643169476486
• 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): 07/14/2020

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-523RNAL
• Device Catalogue Number: MMT-523RNAL
• Device Lot Number: A0523RNALJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2020
• Initial Report FDA Received Date: 07/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 86 YR
• Patient Weight: 68