MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523RNAP; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-523RNAP
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fainting (1847); Hypoglycemia (1912); Loss of consciousness (2418)
Date of Event	04/14/2019
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.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.
Event or Problem Description
Customer called and reported that they received emergency medical assistance and got hospitalized due to low blood glucose on (b)(6) 2019 with blood glucose of around 20 mg/dl at the time of the incident.The customer did not mention how they were treated.The customer experienced symptoms such as fainting.The customer was wearing the insulin pump during the incident.The customer did not allege the pump over delivered insulin.The customer stated they had changed their settings to deliver less insulin for now.Troubleshooting was not completed as the customer declined.The insulin pump will not be returned for analysis.
Additional Manufacturer Narrative
The information that provided in section b5 harm code with the initial report was incorrect.The correct information has been included with this report.(b)(4).
Event or Problem Description
Harm code has been updated to show patient was fainted instead of loss of consciousness as per complaint notes.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523RNAP
• 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: 8548437
• Report Number: 3004209178-2019-87812
• Device Sequence Number: 18922736
• Product Code: OYC
• UDI-Device Identifier: 00643169476493
• UDI-Public: (01)00643169476493
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 07/16/2019

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-523RNAP
• Device Catalogue Number: MMT-523RNAP
• Device Lot Number: A0523RNAPJ
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/16/2019
• Supplement Date Received by Manufacturer: 07/15/2019
• Initial Report FDA Received Date: 04/25/2019
• Supplement Report FDA Received Date: 07/17/2019
• 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-RSVR UNOMED SET
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 64 YR
• Patient Weight: 162