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

Model Number	MMT-723LNAH
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Device Difficult to Program or Calibrate (1496); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/03/2018
Type of Reportable Event	Serious Injury
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
The customer reported via phone call that they were hospitalized because she was not getting enough insulin.The customer¿s blood glucose level was unknown.The customer reported that the reservoir had leak at the 2nd past o ring.The customer was reported that the keypad was not responding, screen went rainbow and dark in places.Customer assisted with troubleshooting.The customer was advised to replace the insulin pump and to revert to the back-up plan.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Additional information has been received which was not included with the initial report.The information has been provided with this report.
Event or Problem Description
The customer was hospitalized for high blood sugar and diabetic ketoacidosis on april 2, 2019.The customer's blood glucose was 498 mg/dl.The customer was released from hospital on (b)(6) 2019.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723LNAH
• 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: 8507856
• Report Number: 3004209178-2019-80633
• Device Sequence Number: 13895065
• Product Code: OYC
• UDI-Device Identifier: 00643169478572
• UDI-Public: (01)00643169478572
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 04/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-723LNAH
• Device Catalogue Number: MMT-723LNAH
• Device Lot Number: A4723LNAHJ
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/03/2019
• Supplement Date Received by Manufacturer: 04/11/2019
• Initial Report FDA Received Date: 04/12/2019
• Supplement Report FDA Received Date: 04/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FRN-UNK-RSVR, UNOMED INF SET
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 27 YR
• Patient Weight: 77