MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP; INSULIN INFUSION PUMP / SENSOR AUGMENTED

Model Number MMT-723NAH

Device Problems Intermittent Continuity (1121); Failure to Reset (1532); Device Displays Incorrect Message (2591)

Patient Problem Hyperglycemia (1905)

Event Date 08/27/2013

Event Type  Injury  

Manufacturer Narrative

The insulin pump passed the displacement, basic occlusion, occlusion, priming and excessive no delivery alarm tests.There was no excessive no delivery alarm and all buttons functioned properly.There was no damage on the keypad assembly.(b)(4).

Event Description

Customer's mother reported via phone call keypad anomaly, no delivery alarm and high blood glucose levels.Customer's blood glucose level was 433 mg/dl.Customer treated their high blood glucose with manual injection.Troubleshooting for no delivery was performed.Customer's mother advised the patient went to school and had no units left.Customer advised the no delivery alarm was a recurring issue.Customer advised the alarm occurred during bolus delivery and manual prime.Troubleshooting for keypad anomaly was performed.Customer advised they were unable to rewind and the buttons would respond intermittently.Customer advised they would press the buttons several times until it would work.Customer was advised to discontinue use of the device and revert to a backup plan.Customer was advised that the device would be replaced and agreed to return the product for analysis.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
• Type of Device: INSULIN INFUSION PUMP / SENSOR AUGMENTED
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50; road 31 km 24.4; juncos PR 00777 3869
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50; road 31 km 24.4; juncos PR 00777 3869
• Manufacturer Contact: gerwin de graaff ; 18000 devonshire street; northridge, CA 91325-1219 ; 8185764805
• MDR Report Key: 5497905
• MDR Text Key: 40231632
• Report Number: 3004209178-2016-91031
• Device Sequence Number: 1
• Product Code: OYC
• Combination Product (y/n): N
• PMA/PMN Number: P980022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 09/24/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-723NAH
• Device Catalogue Number: MMT-723NAH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2013
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/30/2013
• Was Device Evaluated by Manufacturer?: Yes
• 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 Outcome(s): Other
• Patient Age: 12 YR
• Patient Weight: 47