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

Model Number	MMT-523NAB
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	06/29/2017
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 he experienced high blood glucose and a no delivery alarm.He said that he had a blood glucose of 271 mg/dl at 9:30 pm the night prior and 490 mg/dl this morning.He said that after he received 1 unit, he got a no delivery alarm.He also had a blood glucose of 445 mg/dl, 400 mg/dl, 326 mg/dl, 248 mg/dl and 199 mg/dl.During high blood glucose troubleshooting, the customer said that their blood glucose was 326 mg/dl at the time of the event and that their current blood glucose was 400 mg/dl.The customer treated their high blood glucose with their pump.He said that his drive support cap appeared normal.He said that his doctor recently changed his settings because of his high blood glucose.The customer was assisted with performing the high-pressure test and the test passed.He was advised to change the entire set, reservoir and insulin and treat per his doctor¿s instructions.The insulin pump is being returned for analysis.
Additional Manufacturer Narrative
Findings: pump passed all functional testing including the displacement, operating currents, rewind, basic occlusion, occlusion, prime and excessive no delivery test.Pump received with cracked case at the display window corner, cracked reservoir tube lip, minor scratched lcd window, cracked case and cracked battery tube threads.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523NAB
• 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: 6755758
• Report Number: 2032227-2017-32623
• Device Sequence Number: 16363360
• Product Code: OYC
• UDI-Device Identifier: 00643169077645
• UDI-Public: (01)00643169077645
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 10/18/2017

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-523NAB
• Device Catalogue Number: MMT-523NAB
• Device Lot Number: A7523NABJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2017
• Initial Date Received by Manufacturer: 07/02/2017
• Supplement Date Received by Manufacturer: 10/13/2017
• Initial Report FDA Received Date: 07/31/2017
• Supplement Report FDA Received Date: 10/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 185