MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722WWB; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number MMT-722WWB

Device Problems Crack (1135); Out-Of-Box Failure (2311); Material Protrusion/Extrusion (2979)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/18/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned.The device will be returned for analysis and further information will follow once the analysis has been completed.No conclusion can be drawn at this time.

Event Description

The customer was reported via phone call that, the customer received with drive support cap was sticking out and case was cracked.The blood glucose was 212 mg/dl at the time of the incident.The insulin pump will returned for analysis.

Manufacturer Narrative

Unit was received with loose/protruded drive support disk.Unit was received with minor scratched display window, cracked case at display window corner, cracked battery tube threads, partially broken reservoir tube lip and cracked end cap.Unable to perform basic occlusion and occlusion test due to cracked end cap.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722WWB
• 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: 7081477
• MDR Text Key: 93720989
• Report Number: 2032227-2017-70098
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00613994402004
• UDI-Public: (01)00613994402004
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-722WWB
• Device Catalogue Number: MMT-722WWB
• Device Lot Number: A5722WWBJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/27/2018
• 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