MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAH; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-723NAH
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	10/01/2016
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 the blood glucose was high and the insulin pump alarmed motor error.The customer¿s blood glucose level was 530 mg/dl at the time of the incident.Patient's current blood glucose is 130 mg/dl.Customer had the first motor error in (b)(6) 2017.She had another one in (b)(6) 2017, (b)(6) 2017 and (b)(6) 2017.Customer reported they have a back-up plan available.Customer treated high blood glucose by giving bolus with pump.Customer reported they have not contacted their healthcare professional regarding the high blood glucose.Customer reports the drive support cap is loose.They are transitioning from pediatric to adult.The customer was advised to discontinue use of the insulin pump and to revert to the back-up plan.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
The pump alarmed motor error during the basic occlusion test due to a loose/protruded drive support disk.The motor was tested outside of the device and passed.Pump received with cracked battery tube thread, broken belt clip slot, broken reservoir tube lip, cracked reservoir tube, cracked reservoir tube window, cracked case near display window corners, cracked on display window, stained end cap sticker, stained address/serial number label and minor scratches on display window noted.No moisture damage on electronics and motor assembly noted.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAH
• 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: 6847285
• Report Number: 2032227-2017-45233
• Device Sequence Number: 16160205
• Product Code: OYC
• UDI-Device Identifier: 00613994904324
• UDI-Public: (01)00613994904324
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2018

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-723NAH
• Device Catalogue Number: MMT-723NAH
• Device Lot Number: A5723NAHJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2017
• Initial Date Received by Manufacturer: 08/28/2017
• Supplement Date Received by Manufacturer: 02/20/2018
• Initial Report FDA Received Date: 09/06/2017
• Supplement Report FDA Received Date: 03/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 20 YR
• Patient Weight: 190