MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 640G INSULIN PUMP MMT-1711K; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number MMT-1711K

Device Problems Obstruction of Flow (2423); Patient Device Interaction Problem (4001)

Patient Problems Hyperglycemia (1905); Blood Loss (2597)

Event Date 04/07/2020

Event Type  malfunction  

Manufacturer Narrative

Pump received with stained keypad overlay, detached/missing reservoir retainer ring and missing reservoir tube lip o-ring noted.The test reservoir does not stay locked in place due to detached/missing retainer.Pump passed the self test, rewind test, prime/seating test, basic occlusion test and force sensor test.Unable to perform displacement test, occlusion test and unable to confirm unexpected no delivery/insulin flow blocked alarm due to detached/missing reservoir retainer ring.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.(b)(4).

Event Description

Information received by medtronic indicated that the insulin pump had crack and peachy looking color.Customer stated no errors and yesterday did set change and had a high reading same one and blood in his tubing.No harm requiring medical intervention was reported.The insulin pump will be returned for analysis.

• Brand Name: 640G INSULIN PUMP MMT-1711K
• 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; * 00777-3869
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386; * 00777-3869
• Manufacturer Contact: gerwin de graaff ; ceiba norte ind. park #50 road; juncos 00777--386 ; * 00777-3869 ; 8185464805
• MDR Report Key: 10768826
• MDR Text Key: 214120750
• Report Number: 2032227-2020-199664
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00763000192136
• UDI-Public: (01)00763000192136
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 11/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-1711K
• Device Catalogue Number: MMT-1711K
• Device Lot Number: HG35088
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2020
• Date Manufacturer Received: 10/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2019
• 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