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

Model Number	MMT-523NAS
Medical Device Problem Codes	Device Alarm System (1012); Mechanical Problem (1384); Date/Time-Related Software Problem (2582); Power Problem (3010); Patient Device Interaction Problem (4001); Priming Problem (4040)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.
Event or Problem Description
The customer reported via phone call that their insulin squirts when priming and clock did not kept time.The customer¿s blood glucose level was unknown at the time of the incident.Customer stated that the insulin pump had rejecting new batteries and rewind was louder and screen was dim and hard to see.Customer stated that the insulin pump had motor error and alarm not as loud and crack by reservoir and rim around insulin pump was broken.The customer was advised to discontinue use of the insulin pump and to revert to the back-up plan.The device will not be returned for analysis.
Additional Manufacturer Narrative
Pump passed the displacement test but motor error alarm during prime/fill the basic occlusion test due to protruded drive support disk.Unable to perform the occlusion, prime/a33 and excessive no delivery test due to loose drive support disk.Pump received with minor scratched lcd window, partial broken reservoir tube lip and missing reservoir tube o-ring.The p-cap locks into the reservoir compartment properly noted.No time/clock anomaly, no audio/vibrate anomaly and no failed battery test alert noted.Motor passed motor test.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523NAS
• 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
• MDR Report Key: 9442795
• Report Number: 2032227-2019-129590
• Device Sequence Number: 11506383
• Product Code: OYC
• UDI-Device Identifier: 00643169202344
• UDI-Public: (01)00643169202344
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 05/05/2020

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-523NAS
• Device Catalogue Number: MMT-523NAS
• Device Lot Number: B1523NASJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2019
• Supplement Date Received by Manufacturer: 04/29/2020
• Initial Report FDA Received Date: 12/09/2019
• Supplement Report FDA Received Date: 05/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 190