MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-522NAL; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-522NAL
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	03/01/2017
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.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.
Event or Problem Description
The customer¿s spouse reported via phone call that the customer had been experiencing high blood glucose.The insulin pump was not giving them a no delivery alarm.They would know they were high from the meter or when they start feeling symptoms of high blood glucose.The customer felt that the issues had to do with removing the set while in the shower.The customer noticed that after she reconnects and treats her blood glucose, instead of going back to normal they would start to go up.The customer had treated 8-9 times with the insulin pump but their blood glucose still would not go down until they treated with a manual syringe and an infusion set change.The customer¿s blood glucose level at the time of the incident was 500 mg/dl.The customer¿s current blood glucose level was 278 mg/dl.The customer stated they will call back to troubleshoot when it was time to remove the set from their body.The customer did not want to disconnect from the insulin pump during the call because their blood glucose levels were normal.The device will not be returned for analysis.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-522NAL
• 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: 6667841
• Report Number: 2032227-2017-23622
• Device Sequence Number: 11233330
• Product Code: OYC
• UDI-Device Identifier: 00613994402110
• UDI-Public: (01)00613994402110
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 06/26/2017

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-522NAL
• Device Catalogue Number: MMT-522NAL
• Device Lot Number: A5522NALJ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2017
• Initial Report FDA Received Date: 06/26/2017
• 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: Other
• Patient Age: 46 YR
• Patient Weight: 120