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

Model Number	MMT-723LNAL
Health Effect - Clinical Codes	Hyperglycemia (1905); Elevated ketones/Diabetic Ketoacidosis (2364)
Date of Event	05/10/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A complete analysis and testing of the insulin pump showed that it was functioning properly and passed all functional testing.  after testing it was concluded that the device operated within specifications.  the insulin pump was 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. the insulin pump passed the delivery accuracy test. no excessive no delivery alarms noted. the bolus wizard functioning properly per bolus wizard on the user guide. the insulin pump was received with cracked case at the display window corners, display window, belt clip slot and battery tube threads. the insulin pump was received with stained end cap sticker. the insulin pump was received with minor scratched display window and case.
Event or Problem Description
Customer reported via phone call, the customer was hospitalized due to high blood glucose of 412 mg/dl and diabetic ketoacidosis on (b)(6)2017.  customer was at home treating on a sliding scale for high blood glucose and she went into diabetic ketoacidosis at 3 am. she woke up and called the ambulance as she thought was ill. her blood glucose was 179 mg/dl and then by 12 the ambulance got there and got her out of diabetic ketoacidosis. two hours later her blood glucose was up at 411 mg/dl and she went into diabetic ketoacidosis and was admitted.  customer was experiencing symptoms such as vomiting and feeling ill. the customer was wearing the insulin pump at the time of the hospitalization. customer was wearing the insulin pump at the time of the hospitalization. troubleshooting was performed on the insulin pump. the drive support cap was reported as normal. customer wasn't wearing the pump at the time so customer was unable to check for leaks or air bubbles. customer declined to check for site and insulin issues. customer stated the insulin pump always alarm no delivery and that night the cannula was not bent. customer did check her settings and no anomalies were noted. customer declined performing the high pressure test. the customer requested the device to be exchanged as customer stated there is an issue with the device. as customer was removed of the device and when she was put back on the device customer was going into diabetic ketoacidosis again. the customer is returning the device for analysis.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723LNAL
• 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: 6615624
• Report Number: 2032227-2017-20737
• Device Sequence Number: 10928415
• Product Code: OYC
• UDI-Device Identifier: 00613994904508
• UDI-Public: (01)00613994904508
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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
• Report Date (Section B): 06/06/2017

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-723LNAL
• Device Catalogue Number: MMT-723LNAL
• Device Lot Number: A000202977
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2017
• Initial Report FDA Received Date: 06/06/2017
• 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: Hospitalization
• Patient Age: 47 YR
• Patient Weight: 180