MAUDE Adverse Event Report: MEDTRONIC MINIMED RESERVOIR 3ML MMT-332A; PUMP, INFUSION

Model Number MMT-XXX

Device Problems Failure to Power Up (1476); Failure to Prime (1492)

Patient Problem Vomiting (2144)

Event Date 05/15/2018

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¿s mother was reported via phone call that, the customer was hospitalized on (b)(6) 2018 due to diabetes ketoacidosis with high blood glucose of the 544 mg/dl and also stated that, the insulin pump will not turn on.The insulin pump kept saying load reservoir and changed and load reservoir, primed the tubing, it would not deliver.The significant events leading to hospitalization were stomach pain and vomiting.Customer was wearing the pump at time of hospitalization.Customer declined to troubleshoot for no delivery when priming the tubing and troubleshooting was not done for the insulin pump not turning on.The device is expected to be returned for analysis.

• Brand Name: RESERVOIR 3ML MMT-332A
• 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: 7608331
• MDR Text Key: 111301245
• Report Number: 2032227-2018-06183
• 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: 06/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2018
• 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: 05/18/2018
• 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): Other
• Patient Age: 15 YR
• Patient Weight: 155