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

Model Number	MMT-523NAS
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Device Difficult to Program or Calibrate (1496)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	07/16/2020
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 experienced low blood glucose.The customer blood glucose level was 39 mg/dl.Customer reported that the insulin pump button did not responding.Customer reported the time clock does advance.No alarms occurred during or after the time that the buttons were not responding.Customer declined troubleshooting.The insulin pump will not be returned for analysis.
Additional Manufacturer Narrative
Device received with no button response at esc, act, up and down due to unlocked j2/lcd keypad connector during visual inspection.No button error alarm during testing.Unable to perform the displacement and self test or verify missing segment/partial display due to unresponsive buttons.(b)(4).

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523NAS
• 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: 10306010
• Report Number: 2032227-2020-150198
• Device Sequence Number: 11612598
• Product Code: OYC
• UDI-Device Identifier: 00643169446427
• UDI-Public: (01)00643169446427
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 10/08/2020

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-523NAS
• Device Catalogue Number: MMT-523NAS
• Device Lot Number: B3523NASJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2020
• Initial Date Received by Manufacturer: 07/16/2020
• Supplement Date Received by Manufacturer: 10/05/2020
• Initial Report FDA Received Date: 07/21/2020
• Supplement Report FDA Received Date: 10/08/2020
• 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,UNOMED SET
• Outcome Attributed to Adverse Event: Other
• Patient Age: 65 YR
• Patient Weight: 69