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 Codes	Obstruction of Flow (2423); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	06/05/2020
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.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 experiencing low blood glucose.Blood glucose level at the time of the incident was 50 mg/dl.Customer stated that had no delivery alarm.Customer stated that was unable to get past the time and date setup screen after the insulin pump restarted a battery change.Customer stated that has treated with food.Customer has been experiencing low blood glucose for about 3 weeks.Customer declined to troubleshoot insulin pump for low blood glucose because he attributes it to the settings.The insulin pump will 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: 10231609
• Report Number: 2032227-2020-141488
• Device Sequence Number: 2425980
• Product Code: OYC
• UDI-Device Identifier: 00643169446472
• UDI-Public: (01)00643169446472
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 07/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-723NAS
• Device Catalogue Number: MMT-723NAS
• Device Lot Number: B3723NASJ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2020
• Initial Report FDA Received Date: 07/06/2020
• 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 332A-RSVR, UNOMED SET
• Outcome Attributed to Adverse Event: Other
• Patient Age: 69 YR
• Patient Weight: 96