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

Model Number	MMT-723LNAP
Medical Device Problem Codes	Mechanical Problem (1384); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/04/2019
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.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
It was reported that the insulin pump had motor error.The customer¿s blood glucose was unknown at the time of incident.The customer was assisted with troubleshooting.It was reported that motor error was occurred few days ago.Dome label sticker on the end of was not present on the insulin pump.The customer was advised to replace and to discontinue use of the insulin pump and to revert to the back-up plan.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
No motor error alarm noted during testing.Device passed rewind test, basic occlusion test, occlusion test, prime or a33 test, excessive no delivery test and displacement test.The motor was tested outside the device and passed.Device had cracked battery tube threads, cracked reservoir tube lip, broken belt clip slot.No missing end cap sticker noted.The reservoir tube lip was tested with the test reservoir locked in place properly and no anomaly noted.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723LNAP
• 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: 9480414
• Report Number: 2032227-2019-133962
• Device Sequence Number: 3987242
• Product Code: OYC
• UDI-Device Identifier: 00643169933163
• UDI-Public: (01)00643169933163
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 04/02/2020

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-723LNAP
• Device Catalogue Number: MMT-723LNAP
• Device Lot Number: A6723LNAPJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2020
• Initial Date Received by Manufacturer: 12/11/2019
• Supplement Date Received by Manufacturer: 03/25/2020
• Initial Report FDA Received Date: 12/17/2019
• Supplement Report FDA Received Date: 04/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1