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

Model Number MMT-523NAS

Device Problems Break (1069); Component Missing (2306); Malposition of Device (2616); Scratched Material (3020)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/08/2016

Event Type  malfunction  

Manufacturer Narrative

The insulin pump was received with a cracked case at the display window corner, a broken reservoir tube lip, a minor scratched lcd window, a cracked case at the reservoir tube window corner, a missing reservoir tube o-ring, a missing end cap sticker, a stained serial number label, and broken battery tube threads.

Event Description

The customer reported via phone call that she does not have the label on the back of the insulin pump.Customer stated that she needs a battery cap because it is broken and the battery won't stay in.Customer stated that she may have dropped the battery cap.Customer was advised to disconnect from the pump.Customer stated that a piece is missing by the battery compartment.Customer stated that the battery cap is also damaged and there are 3 scratches on the screen.Customer saw the sensor graph but she does not wear the sensor.Customer was assisted with turning off the sensor feature in the pump.Customer's last blood glucose level was 111 mg/dl.Customer was advised to discontinue use of the pump and revert to a back-up plan.Customer was advised that the pump will need to be replaced.

• 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: 5776567
• MDR Text Key: 49665808
• Report Number: 3004209178-2016-59442
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-523NAS
• Device Catalogue Number: MMT-523NAS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/15/2016
• 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 Age: 50 YR