MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723LNAB; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-723LNAB
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/17/2017
Type of Reportable Event	Malfunction
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.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 their insulin pump had finish loading alarm.The customer¿s blood glucose level was 144 mg/dl.Customer states they were refilling reservoir and he was trying to fill the tubing and there was no insulin going through the act button was not working or the pump wasn't working to push out any insulin.Customer states the time is correct on the pump is able to use the button but it will not move from the load reservoir screen.Customer is not able to clear the alarm.Advised clearing the alarm resumes current basal delivery.Finish loading alarm occurred.Advised the pump will need to be replaced.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Unit passed self test.No unexpected audio/beep anomaly noted.Unit had minor scratched lcd window, cracked case near display window corners, cracked battery tube threads, cracked reservoir tube lip, missing end cap sticker and cracked lcd window.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723LNAB
• Common Device Name: PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• MDR Report Key: 6894611
• Report Number: 2032227-2017-52868
• Device Sequence Number: 10921820
• Product Code: OYC
• UDI-Device Identifier: 00613994748850
• UDI-Public: (01)00613994748850
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-723LNAB
• Device Catalogue Number: MMT-723LNAB
• Device Lot Number: A000168173
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2017
• Initial Date Received by Manufacturer: 09/18/2017
• Supplement Date Received by Manufacturer: 02/03/2018
• Initial Report FDA Received Date: 09/26/2017
• Supplement Report FDA Received Date: 02/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 370