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

Model Number	MMT-523LNAH
Medical Device Problem Codes	Device Difficult to Program or Calibrate (1496); Moisture or Humidity Problem (2986)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.Device received with unresponsive buttons due to moisture damage at keypad traces.No button error alarm noted.Traces of corrosion found at the electronic assembly and motor assembly per visual inspection.Unable to perform the displacement, operating current and self test due to unresponsive buttons.The asr exemption e2015043 was revoked on february 4, 2019.This event was previously reported as an asr.Additional information or analysis results regarding this event will be reported as an mdr.
Event or Problem Description
It was reported that there was liquid in the chamber.The buttons were having errors and were sticky.She was having problems with the escape button.Customer's blood glucose level was not reported.The device was not returned.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523LNAH
• 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: 9360528
• Report Number: 2032227-2019-121327
• Device Sequence Number: 14109996
• Product Code: OYC
• UDI-Device Identifier: 00643169151284
• UDI-Public: (01)00643169151284
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 11/21/2019

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-523LNAH
• Device Catalogue Number: MMT-523LNAH
• Device Lot Number: A000289667
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2019
• Initial Report FDA Received Date: 11/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 73