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

Model Number MMT-523LNAS

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Naturally Worn (2988)

Patient Problems Hyperglycemia (1905); Diabetic Ketoacidosis (2364)

Event Date 10/26/2016

Event Type  Injury  

Manufacturer Narrative

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.(b)(4).

Event Description

The customer reported via phone call of being hospitalized for high blood glucose of 565mg/dl and diabetic ketoacidosis.Troubleshooting found that the keypad buttons are not responsive and the arrow buttons are worn down to the metal.Customer was advised to discontinue use of the device and revert to a back-up plan per their doctor's instruction.The customer was also advised that the device would be replaced and agreed to return the product for analysis.Customer declined high blood glucose troubleshooting.

Manufacturer Narrative

The insulin pump passed all functional testing including the displacement, rewind, basic occlusion, occlusion, prime and excessive no delivery test.However, insulin pump was received with intermittent button response.The insulin pump was received with cracked battery tube threads, keypad overlay worn and minor scratched lcd window.

Manufacturer Narrative

The insulin pump passed the displacement accuracy test.

• 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 MINIMED; 18000 devonshire street; northridge CA 91325 1219
• Manufacturer Contact: gerwin de graaff ; 18000 devonshire street; northridge, CA 91325-1219 ; 8185764805
• MDR Report Key: 6073460
• MDR Text Key: 59008005
• Report Number: 2032227-2016-39397
• 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: Patient
• Type of Report: Initial,Followup,Followup
• Report Date: 04/06/2017

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
• Device Operator: Lay User/Patient
• Device Model Number: MMT-523LNAS
• Device Catalogue Number: MMT-523LNAS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/28/2016
• Initial Date FDA Received: 11/02/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/01/2016; 04/27/2017
• 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): Hospitalization; Other
• Patient Age: 43 YR
• Patient Weight: 59