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

Model Number MMT-523NAP

Device Problem No Apparent Adverse Event (3189)

Patient Problems Purulent Discharge (1812); Hyperglycemia (1905); Unspecified Infection (1930); Pocket Erosion (2013); Skin Irritation (2076)

Event Date 07/25/2018

Event Type  Injury  

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 Description

The customer¿s mother reported via phone call that they were hospitalized due to high blood glucose on (b)(6) 2018 with blood glucose of 400 mg/dl.The customer's different blood glucose was 200 mg/dl and 215 mg/dl.The customer did not provide details regarding symptoms of their high blood glucose episodes.The customer was treated with emergency room.Troubleshooting was done for high blood glucose.The insulin pump will not be returned for analysis.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523NAP
• Type of Device: 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
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386
• Manufacturer Contact: gerwin de graaff ; ceiba norte ind. park #50 road; juncos 00777--386 ; 8185464805
• MDR Report Key: 7932815
• MDR Text Key: 122616047
• Report Number: 2032227-2018-36799
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00643169507197
• UDI-Public: (01)00643169507197
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-523NAP
• Device Catalogue Number: MMT-523NAP
• Device Lot Number: B4523NAPJ
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/20/2018
• Date Device Manufactured: 12/28/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: FRN-MMT-326-RSVRUNOMED INF SET
• Patient Outcome(s): Hospitalization
• Patient Age: 11 YR
• Patient Weight: 95