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

Model Number	MMT-523NAH
Health Effect - Clinical Codes	Hyperglycemia (1905); Hypoglycemia (1912)
Date of Event	04/16/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
All operating currents are within specification.No unexpected low batt or off no power alarms noted.Unit passed off no power test, self test, a21 error test and displacement test.Unit received with cracked case on display window corners, minor scratched lcd window, cracked reservoir tube window corners, broken reservoir tube lip, missing reservoir tube o-ring and cracked battery tube threads.Reservoir not able to lock in place due to broken off reservoir tube lip.Unable to complete functional test including basic occlusion test and occlusion test due to broken reservoir tube lip.Unable to confirm damage battery cap due to original battery cap not received with pump.
Event or Problem Description
Customer called and reported that they received emergency medical assistance due to low blood glucose on (b)(6) 2017, with blood glucose of 13 mg/dl at time of the incident.The customer's blood glucose was 264 g/dl at the time of the call.The customer was given intravenous glucose to treat the low blood glucose.The customer experienced symptoms such as seizures and loss of consciousness.The customer was wearing the insulin pump during the incident.Troubleshooting was not completed as the customer saw their health care professional and had their settings adjusted.The customer also reported high blood glucose levels caused by the reservoir not staying within its compartment, which was damaged.The insulin pump will be returned for analysis.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523NAH
• 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: 6615759
• Report Number: 3004209178-2017-52753
• Device Sequence Number: 10786948
• Product Code: OYC
• UDI-Device Identifier: 00643169077652
• UDI-Public: (01)00643169077652
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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-523NAH
• Device Catalogue Number: MMT-523NAH
• Device Lot Number: A7523NAHJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2017
• 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
• Patient Age: 37 YR
• Patient Weight: 160