MAUDE Adverse Event Report: MEDTRONIC MINIMED INFUSION SET; FPA

Model Number MMT-UNK

Device Problem Device Displays Incorrect Message (2591)

Patient Problems Hyperglycemia (1905); Vomiting (2144); Diabetic Ketoacidosis (2364); Polydipsia (2604)

Event Date 08/19/2013

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.Note: this is a remediation mdr.Medtronic diabetes implemented revised mdr reportability criteria effective on july 1, 2014.Subsequently, medtronic diabetes conducted a one year retrospective review of complaints.This event was retrospectively identified to be reportable based on the revised mdr reportability criteria.

Event Description

Customer's grandfather reported via phone call high blood glucose levels and hospitalization.Customer's blood glucose level was over 600 mg/dl.Customer received the no delivery alarm and felt like they were coming down with the flu.Customer was thirsty, vomiting and was sent to the emergency room.Customer experienced diabetic ketoacidosis and treated their high blood glucose via insulin pump.Customer was wearing the insulin pump when they were hospitalized and they had a bent cannula.

• Brand Name: INFUSION SET
• Type of Device: FPA
• 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: 5581686
• MDR Text Key: 42811740
• Report Number: 2032227-2016-09182
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 09/05/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-UNK
• Device Catalogue Number: MMT-UNK
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/05/2013
• 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: 57 YR