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

Model Number MMT-751NAS

Device Problem Insufficient Information (3190)

Patient Problems Hyperglycemia (1905); Diabetic Ketoacidosis (2364); Irritability (2421)

Event Date 11/20/2015

Event Type  Injury  

Manufacturer Narrative

The insulin pump passed functional test including displacement test, rewind, basic occlusion, occlusion, prime, and excessive no delivery alarm test.The pump functioned properly.The pump was received with minor scratched lcd window, cracked reservoir tube lip, and cracked battery tube threads.(b)(4).

Event Description

The customer's mother reported via phone call of high blood glucose readings and hospitalization from the insulin pump.The customer's mother stated that her daughter was hospitalized for diabetic ketoacidosis.The customer was treated with the insulin drip.The mother stated that her daughter was very irritable when her blood glucose was going up.The mother stated that the hospital staff tested her daughter's blood glucose with the hospital meter and drew blood to test the blood glucose.The nursing staff suggested that the customer contact helpline because there might be something wrong with the pump.The customer will be sent a replacement pump per health care provider's instructions.

• 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: 5276056
• MDR Text Key: 32979994
• Report Number: 2032227-2015-72374
• 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: other
• Type of Report: Initial
• Report Date: 11/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-751NAS
• Device Catalogue Number: MMT-751NAS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2015
• Date Manufacturer Received: 12/08/2015
• 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): Hospitalization; Other
• Patient Age: 15 YR
• Patient Weight: 49