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

Model Number MMT-723NAS

Device Problems Naturally Worn (2988); Physical Property Issue (3008)

Patient Problem Hyperglycemia (1905)

Event Date 11/30/2017

Event Type  malfunction  

Manufacturer Narrative

Unit passed the displacement test, rewind, basic occlusion test, occlusion test, prime/a33 test and excessive no delivery test.Unit received without the original battery cap.Unable to verify damage to the original battery cap.The test battery cap was installed and remains in place during testing.No battery cap anomaly noted.No cracked battery tube threads noted.Unit had a slightly corroded battery tube, minor scratched display window, a small crack on the display window, cracked case at display window corner, scratched reservoir tube window and cracked reservoir tube lip.

Event Description

The customer reported via phone call that the insulin pump got damaged.The customer¿s blood glucose level was high between 140 to 160 mg/dl.The customer stated that the threads were worn.The customer declined to troubleshoot for high blood glucose.The insulin pump will be returned for analysis.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAS
• 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
• MDR Report Key: 7599374
• MDR Text Key: 111244961
• Report Number: 3004209178-2018-81022
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00643169202399
• UDI-Public: (01)00643169202399
• 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: Patient
• Type of Report: Initial
• Report Date: 06/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-723NAS
• Device Catalogue Number: MMT-723NAS
• Device Lot Number: B1723NASJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 67 YR
• Patient Weight: 276