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

Model Number	MMT-523NAL
Medical Device Problem Codes	Failure to Cycle (1142); Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/24/2017
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 the insulin pump had a compromised force sensor system alarm and it shuts down and it restarted.The customer¿s blood glucose level was unknown at the time of the incident.The customer stated that the drive support cap appeared normal or recessed.The customer reported that they were not recognizing the reservoir in the insulin pump and it was squirting insulin out.The customer stated that the insulin was squirting out during the manual prime process.The customer stated that the insulin continued to drip after motor stopped during the manual prime process.The customer stated that they were unable to exit the preparing to prime loop and were stuck in rewind complete or bolus delivery loop.The customer stated that they had motor error alarm before.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.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523NAL
• 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: 9534226
• Report Number: 2032227-2019-139906
• Device Sequence Number: 16991436
• Product Code: OYC
• UDI-Device Identifier: 00613994904287
• UDI-Public: (01)00613994904287
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/30/2019

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-523NAL
• Device Catalogue Number: MMT-523NAL
• Device Lot Number: A4523NALJ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/24/2019
• Initial Report FDA Received Date: 12/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 33 YR
• Patient Weight: 91