MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAP; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-723NAP
Medical Device Problem Codes	Mechanical Problem (1384); Obstruction of Flow (2423); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/01/2018
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.Device passed the displacement test.Device received with motor error alarm during the basic occlusion test due to loose/protruded drive support disk.Unable to perform prime/compromised force sensor system test, excessive no delivery test and occlusion test or verify no communication due to motor error alarm.
Event or Problem Description
The customer reported via phone call that the insulin pump had motor error alarm during basal.The customer¿s blood glucose level was 252 mg/dl at the time of incident.Customer reported that the drive support cap was normal.Customer stated that the insulin pump was not exposed to high magnetic field.Customer did not reported motor position encoder error alarm.Customer stated that the insulin pump alarm history contains neither motor position encoder error alarm nor more than one motor error alarm within a 30 day period.Customer performed displacement test and it was passed.Customer stated that the insulin pump had rejected new batteries, random unexplained no delivery alerts, and random insulin pump failure alerts.Customer stated that the insulin pump passed motor error troubleshooting and it was working fine.The insulin pump will not be returned for analysis.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAP
• 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: 9368470
• Report Number: 2032227-2019-122085
• Device Sequence Number: 11318831
• Product Code: OYC
• UDI-Device Identifier: 00643169077720
• UDI-Public: (01)00643169077720
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 11/25/2019

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-723NAP
• Device Catalogue Number: MMT-723NAP
• Device Lot Number: A6723NAPJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2019
• Initial Report FDA Received Date: 11/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 118