MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 630G INSULIN PUMP 630G BLACK MG; INSULIN INFUSION PUMP / SENSOR AUGMENTED

Model Number MMT-1715K

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Hyperglycemia (1905)

Event Date 02/02/2017

Event Type  malfunction  

Manufacturer Narrative

The insulin pump was received with missing retainer.Unable to perform displacement test due to missing retainer.Device was received with scratched casing, minor scratches on lcd window, scratches on display window cover and pillowing keypad overlay.(b)(4).

Event Description

Customer reported via phone call that the clear casing that holds the reservoir had popped out.Customer's blood glucose was 140 mg/dl.Device passed the self-test.Customer was advised to discontinue use of the device and revert to a back-up plan per health care professionals' instructions.Customer was advised that the insulin pump will be replaced.Customer agreed to return the device for analysis.

• Brand Name: 630G INSULIN PUMP 630G BLACK MG
• 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 MINIMED; 18000 devonshire street; northridge CA 91325 1219
• Manufacturer Contact: gerwin de graaff ; 18000 devonshire street; northridge, CA 91325-1219 ; 8185764805
• MDR Report Key: 6757883
• MDR Text Key: 81677344
• Report Number: 2032227-2017-08337
• Device Sequence Number: 1
• Product Code: OYC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/20/2017

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-1715K
• Device Catalogue Number: MMT-1715K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/20/2017
• Initial Date FDA Received: 08/01/2017
• 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 Age: 32 YR
• Patient Weight: 104