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

Model Number	MMT-1755KR
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/10/2019
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
Customer reported via phone call that the insulin pump had critical pump error.The blood glucose level was unknown at the time of incident.The customer stated that they received pump error prior to critical pump error.Troubleshooting was performed for critical pump error.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Incident date has been corrected to (b)(4) 2019.
Additional Manufacturer Narrative
Insulin pump was received as a kit under this.
Additional Manufacturer Narrative
The information provided in section b5 product model has been corrected.
Event or Problem Description
Correction supplemental is requested to update mmt # to 630g insulin pump to mmt-1715kr 630g.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
• 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: 8334139
• Report Number: 3004209178-2019-54848
• Device Sequence Number: 19597324
• Product Code: OYC
• UDI-Device Identifier: 00763000179632
• UDI-Public: (01)00763000179632(17)210103
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Followup,Followup
• Report Date (Section B): 09/09/2019

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 Expiration Date: 01/03/2021
• Device Model Number: MMT-1755KR
• Device Catalogue Number: MMT-1755KR
• Device Lot Number: HG32WD4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2019
• Initial Date Received by Manufacturer: 02/10/2019
• Supplement Date Received by Manufacturer: 03/26/2019; 05/10/2019; 08/29/2019
• Initial Report FDA Received Date: 02/12/2019
• Supplement Report FDA Received Date: 03/27/2019; 05/10/2019; 09/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Weight: 209