MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722NAB; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-722NAB
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	10/08/2017
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 were hospitalized due to diabetic ketoacidosis and high blood glucose on 10/8/17 with blood glucose of 450 mg/dl.The customer's blood glucose was 462 or 463 mg/dl and current blood glucose is 227 mg/dl.The customer experienced symptoms such as nausea, ketones.The customer was treated with an insulin drip.The customer was off the pump prior to hospitalization for less than 48 hours.The customer declined troubleshoot for high blood glucose.The insulin pump will not be returned for analysis.
Additional Manufacturer Narrative
Pump passed functional testings including displacement test, rewind test, basic occlusion test, occlusion test, prime test and excessive no delivery test.Unit passed the delivery accuracy test.Unit was received with normal operating currents and no unexpected off no power alarm or low battery alarm noted.Unit was received with cracked case at display window corner, cracked lcd window, minor scratched lcd window, cracked battery tube threads, cracked reservoir tube lip and stained end cap sticker.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722NAB
• 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: 6956654
• Report Number: 2032227-2017-59382
• Device Sequence Number: 795850
• Product Code: OYC
• UDI-Device Identifier: 00613994271433
• UDI-Public: (01)00613994271433
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 04/13/2018

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-722NAB
• Device Catalogue Number: MMT-722NAB
• Device Lot Number: A2722NABJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2017
• Initial Date Received by Manufacturer: 10/10/2017
• Supplement Date Received by Manufacturer: 03/26/2018
• Initial Report FDA Received Date: 10/17/2017
• Supplement Report FDA Received Date: 04/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 24 YR