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

Model Number MMT-751NAB

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Hyperglycemia (1905); Sleep Dysfunction (2517); Polydipsia (2604)

Event Date 04/16/2016

Event Type  Injury  

Manufacturer Narrative

Pump passed functional testings including displacement test, rewind, basic occlusion, occlusion, prime and no delivery tests.No delivery alarm functioned properly.The insulin pump was received with normal operating currents and no unexpected off no power or low battery alarm noted.The insulin pump had cracked case at display window corner, cracked battery tube threads and cracked reservoir tube lip.

Event Description

The customer reported via phone call that they experienced high blood glucose.The customer's blood glucose was 548 mg/dl at the time of incident.Customer treated their blood glucose with manual injections and the insulin pump.It was also found the customer was feeling thirsty and sleepy due to their high blood glucose.Troubleshooting did not find any leaks or air bubbles present on the insulin pump.It was also found the insulin pump failed the high pressure test twice during troubleshooting.The customer's current blood glucose was 308 mg/dl.The customer agreed to return the insulin pump for analysis.

• 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 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: 5660643
• MDR Text Key: 45331804
• Report Number: 3004209178-2016-48796
• 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: 04/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-751NAB
• Device Catalogue Number: MMT-751NAB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/02/2016
• 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: 38 YR
• Patient Weight: 78