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

Model Number MMT-1712P

Device Problems Crack (1135); Device Dislodged or Dislocated (2923)

Patient Problem Hyperglycemia (1905)

Event Date 01/25/2016

Event Type  malfunction  

Manufacturer Narrative

The insulin pump was unable to perform displacement test due to missing retainer.The pump was received with minor scratched lcd window, scratched case, pillowing keypad overlay and missing reservoir tube o-ring.No crack was found around reservoir compartment.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 of damage on the insulin pump.The customer's blood glucose level was 246 mg/dl at the time of the incident.The customer stated that there was a crack around the reservoir compartment.The customer stated that the reservoir o-ring was dislodged.The customer stated that the pump was not dropped or bumped.The product was returned 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: 6377710
• MDR Text Key: 69342049
• Report Number: 3004209178-2017-93787
• Device Sequence Number: 1
• Product Code: OYC
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 02/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-1712P
• Device Catalogue Number: MMT-1712P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/10/2017
• Initial Date FDA Received: 03/03/2017
• 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