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

Model Number	MMT-723LNAP
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	02/03/2018
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.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's parent reported via phone call that the customer was hospitalized due to high blood glucose and diabetic ketoacidosis on (b)(6) 2018 blood glucose of over 600 mg/dl.The customer experienced symptoms such as pain, thirst and frequent trip to the bathroom.The customer's blood glucose reading went down to 595 mg/dl after treatment with insulin pump and manual injection.Customer's blood glucose reading went back up a few minutes after and was taken to the hospital.The customer was wearing the insulin pump during the hospitalization.Customer's parent declined high blood glucose troubleshooting.The customer¿s parent also reported that the insulin pump alarmed button error.The customer¿s blood glucose was unknown at the time of incident.Customer¿s parent stated that the insulin pump act button was hard to push.Button error troubleshooting was performed and unable to confirm if the time is advancing.The customer¿s parent was advised to have the customer discontinue use of pump and revert to back-up plan.The insulin pump is not expected to return for analysis.
Additional Manufacturer Narrative
Device received with all operating currents within specification and passed functional testing including the rewind, basic occlusion test, occlusion test, prime test, excessive no delivery test, self test, unexpected restart error test and displacement test.Device passed the delivery accuracy test.Device received with intermittent buttons due to corroded keypad traces.No button error alarms noted.No traces of moisture were noted at electronic or motor assemblies per visual inspection.Device received with cracked case at the reservoir tube.Device received with minor scratched display window and case.Device received with stained end cap sticker and back address serial number label.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723LNAP
• 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: 7282972
• Report Number: 2032227-2018-01568
• Device Sequence Number: 18865906
• Product Code: OYC
• UDI-Device Identifier: 00613994904492
• UDI-Public: (01)00613994904492
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2019

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-723LNAP
• Device Catalogue Number: MMT-723LNAP
• Device Lot Number: A000202976
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2018
• Initial Date Received by Manufacturer: 02/06/2018
• Supplement Date Received by Manufacturer: 03/01/2019
• Initial Report FDA Received Date: 02/20/2018
• Supplement Report FDA Received Date: 03/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 22 YR
• Patient Weight: 110