MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 640G INSULIN PUMP=-; INSULIN INFUSION PUMP / SENSOR AUGMENTED

Model Number MMT-1712K

Device Problems Structural Problem (2506); Naturally Worn (2988)

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

Event Date 08/30/2016

Event Type  malfunction  

Manufacturer Narrative

The insulin pump was received with critical pump error and pump error 35 was present in long trace file due to corrosion on force sensor assembly.We were unable to perform displacement test, rewind test, prime/seating test, basic occlusion test, force sensor test, occlusion test, sleep current measurement, active current measurement and self-test due to critical pump errors.The insulin pump was received with scratched casing and minor scratches on lcd window.The insulin pump was received with pillowing keypad overlay, cracked case on battery tube area, peeling end cap address label, moisture damage on motor assembly and severe corrosion on all electronic assemblies.The insulin pump involved in this event is the 640g insulin infusion pump, which is not marketed in the united states.However, the device is similar to the paradigm real-time insulin infusion pump, which is marketed in the united states.

Event Description

It was reported via phone call that the insulin pump's case and display window are worn and damaged.The customer's blood glucose was unknown.The customer agreed to return pump for analysis.

• Brand Name: 640G INSULIN 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: 6252564
• MDR Text Key: 65250357
• Report Number: 3004209178-2017-84036
• Device Sequence Number: 1
• Product Code: OYC
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Report Date: 01/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-1712K
• Device Catalogue Number: MMT-1712K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/04/2017
• 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