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

Model Number	MMT-723RNAS
Medical Device Problem Codes	Device Alarm System (1012); Excess Flow or Over-Infusion (1311); Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	02/03/2020
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 reported via phone call that the customer was hospitalized due to severe low blood glucose.It was also reported that the insulin pump experienced several malfunctions such as; battery dying without receiving a low battery waring, insulin pump administering insulin without prompt and pump making loud noise during rewind.Caller did not have permission to speak on customer¿s behalf and did not want customer to speak with helpline in order to provide more information.Insulin pump is not expected to return.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723RNAS
• 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: 9704925
• Report Number: 3004209178-2020-69281
• Device Sequence Number: 16973991
• Product Code: OYC
• UDI-Device Identifier: 00643169476677
• UDI-Public: (01)00643169476677
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/13/2020

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-723RNAS
• Device Catalogue Number: MMT-723RNAS
• Device Lot Number: A0723RNASJ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2020
• Initial Report FDA Received Date: 02/13/2020
• 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-UNK-RSVR,UNOMED SET
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 57 YR