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

Model Number	MMT-523LNAL
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/22/2019
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.The device will be returned for analysis and further information will follow once the analysis has been completed.No conclusion can be drawn at this time.
Event or Problem Description
The customer reported via phone call that the screen of insulin pump was black.The customer¿s blood glucose level was unknown at the time of the incident.Customer stated that they were not able to saw the screen very well.Customer stated that the drive support cap was indented.Customer stated that the screen was dim on main menu.The customer was assisted with troubleshooting and reported that the reservoir lip ring was not damaged.The customer was advised that the insulin pump needed to be replaced and was advised to discontinue use of the insulin pump and revert to the backup plan.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Device received with blank display due to moisture damage on the electronics assembly.Unable to perform all functional testing including the operating currents, a21 error test, rewind, basic occlusion, occlusion, prime or a33 and excessive no delivery test or verify led anomaly and missing segment or partial display anomaly due to blank display.Device received with moisture damage motor, vibrator and battery tube assembly.Device received with cracked case display window corner.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523LNAL
• 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: 8891835
• Report Number: 2032227-2019-46799
• Device Sequence Number: 1617655
• Product Code: OYC
• UDI-Device Identifier: 00643169151291
• UDI-Public: (01)00643169151291
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 09/10/2019

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-523LNAL
• Device Catalogue Number: MMT-523LNAL
• Device Lot Number: A000203494
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2019
• Initial Date Received by Manufacturer: 08/05/2019
• Supplement Date Received by Manufacturer: 08/30/2019
• Initial Report FDA Received Date: 08/14/2019
• Supplement Report FDA Received Date: 09/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 175