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

Model Number	MMT-723NAS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Dyspnea (1816); Hyperglycemia (1905); Nausea (1970); Renal Failure (2041); Vomiting (2144)
Date of Event	05/27/2020
Type of Reportable Event	Serious Injury
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 was reported via phone call that, the customer was hospitalized on (b)(6) 2020 for high blood glucose.The blood glucose at the time of the incident was 300 mg/dl and the other blood glucose value was 127 mg/dl.The customer was hospitalized for 19 days and did not wear the pump in the hospital stated that she went in for diabetes.The significant events leading to hospitalization were her kidneys and liver shut down and went to go on dialysis.The other symptoms were nausea, vomiting, abdominal pain and difficulty breathing.Based on customer report customer does not allege pump was under delivering.The drive support cap appears normal.The troubleshooting was declined for high blood glucose.The insulin pump will not be returned for analysis.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAS
• 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; * 00777-3869
• MDR Report Key: 10177528
• Report Number: 2032227-2020-134200
• Device Sequence Number: 11665390
• Product Code: OYC
• UDI-Device Identifier: 00613994743930
• UDI-Public: (01)00613994743930
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 06/21/2020

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-723NAS
• Device Catalogue Number: MMT-723NAS
• Device Lot Number: A3723NASJ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2020
• Initial Report FDA Received Date: 06/22/2020
• 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-MMT-332-RSVR, UNOMED.INF.SET
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 59 YR
• Patient Weight: 225