MAUDE Adverse Event Report: MEDTRONIC MINIMED RESERVOIR 3ML; PUMP, INFUSION

Model Number MMT-XXX

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); High Test Results (2457); Device Displays Incorrect Message (2591)

Patient Problem Hyperglycemia (1905)

Event Date 05/16/2018

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 customer reported via phone call that they were admitted into the hospital as a result of high blood glucose levels on (b)(6) 2018.The customer was vomiting.They experienced a diabetic ketoacidosis.The customer was off the insulin pump less than 48 hours prior to hospitalization.They stayed overnight with an iv.The insulin pump alarmed button error.Not all of the buttons work.Her blood sugar was 413 mg/dl and she treated with shots.The device was not returned.

• Brand Name: RESERVOIR 3ML
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• Manufacturer (Section G): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• Manufacturer Contact: gerwin de graaff ; 18000 devonshire st.; northridge, CA 91325-1219
• MDR Report Key: 7607275
• MDR Text Key: 111264240
• Report Number: 2032227-2018-06055
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 06/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2018
• 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?: No
• Date Manufacturer Received: 05/16/2018
• 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: 28 YR
• Patient Weight: 119