MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP; OZO

Model Number MMT-751NAP

Device Problem Insufficient Information (3190)

Patient Problem Hyperglycemia (1905)

Event Date 12/05/2016

Event Type  Injury  

Manufacturer Narrative

Insulin pump passed the displacement test.Unit received with motor error alarm during the basic occlusion test due to loose/protruded drive support disk.Unable to perform the unexpected restart error test, prime/delivery test, excessive no delivery test and occlusion test due to motor error alarm.Pump received with normal operating current.Pump passed self-test.Pump passed off no power test.Pump received with minor scratched lcd window, loose drive support disk, cracked case at the display window corners and cracked reservoir tube lip.(b)(4).

Event Description

Customer reported via phone call of having high blood glucose of 400 mg/dl.Customer's blood glucose at the time of call was 448 mg/dl.During troubleshooting, it was found that drive support cap was flushed.Customer was advised that insulin pump would need to be replaced.

• Brand Name: 530G INSULIN PUMP
• Type of Device: OZO
• 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: 6216470
• MDR Text Key: 63686942
• Report Number: 2032227-2016-55964
• Device Sequence Number: 1
• Product Code: OZO
• Combination Product (y/n): N
• PMA/PMN Number: 120010
• 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: 12/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-751NAP
• Device Catalogue Number: MMT-751NAP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/06/2016
• Initial Date FDA Received: 12/30/2016
• 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 Outcome(s): Other
• Patient Age: 66 YR
• Patient Weight: 68