MAUDE Adverse Event Report: MEDTRONIC MINIMED OTHER; INSULIN INFUSION PUMP / SENSOR AUGMENTED

Model Number MMT-XXX

Device Problem Naturally Worn (2988)

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

Event Date 10/26/2016

Event Type  Injury  

Manufacturer Narrative

Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.

Event Description

The nurse of a customer reported via phone call that the insulin pump keypad buttons are worn off down to the metal and it's hard to move from screen to screen.The nurse indicated that the customer is in the hospital with high blood glucose of 565 mg/dl and diabetic ketoacidosis.The nurse did not have the customer's pump and troubleshooting advised customer to call back when they are able.

• Brand Name: OTHER
• Type of Device: INSULIN INFUSION PUMP / SENSOR AUGMENTED
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire street; northridge CA 91325
• 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: 6115752
• MDR Text Key: 60418465
• Report Number: 2032227-2016-43531
• 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: Nurse
• Type of Report: Initial
• Report Date: 10/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-XXX
• Device Catalogue Number: MMT-XXX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 43 YR
• Patient Weight: 59