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

Model Number MMT-523NAP

Device Problems Break (1069); Crack (1135); Naturally Worn (2988)

Patient Problem Hyperglycemia (1905)

Event Date 03/19/2017

Event Type  Injury  

Manufacturer Narrative

Currently it is unknown whether or not the device may have caused or contributed to the event.The device has been returned, but not yet evaluated.Further information will follow once the analysis has been completed.No conclusion can be drawn at this time.

Event Description

The customer reported via phone call that their insulin pump was damaged and that they experienced high blood glucose levels of 400mg/dl to 600mg/dl.The customer's blood glucose level was unknown at the time of the incident.Customer was assisted with troubleshooting for damage.Customer stated that there were cracks and chips on the reservoir compartment.Customer stated that the damage was just from being worn out.The customer declined to troubleshoot for high readings and stated that they treated with manual injection.The customer was advised to discontinue use of the insulin pump and to revert to the back-up plan.The insulin pump was returned for analysis.

Manufacturer Narrative

The insulin pump passed all functional testing including displacement, rewind, basic occlusion, occlusion, prime and excessive no delivery test.The insulin pump was received with minor scratched lcd window, broken reservoir tube lip, cracked case at the display window corners, cracked belt clip slot, cracked battery tube threads and missing reservoir tube o ring.

• 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: 6506155
• MDR Text Key: 73218137
• Report Number: 3004209178-2017-45747
• 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
• Report Date: 04/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2017
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/21/2017
• 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): Other
• Patient Age: 57 YR
• Patient Weight: 70