MAUDE Adverse Event Report: MEDTRONIC MINIMED INFST MM T-975T MIO 2PK 9MM 32IN CLEAR; SET, ADMINISTRATION, INTRAVASCULAR

Model Number MMT-975T

Device Problem Bent (1059)

Patient Problem Hyperglycemia (1905)

Event Date 02/23/2018

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.The device will be returned for analysis and further information will follow once the analysis has been completed.No conclusion can be drawn at this time.

Event Description

Customer reported via phone call that they had a high blood glucose level of over 500 mg/dl.Customer was hospitalized as a result of the elevated blood glucose level which resulted in the customer entering a state of diabetic ketoacidosis.Customer believes that her pump malfunctioned, however, no alarms were reported on the pump.Customer first tried to treat the elevated blood glucose level with a manual injection of insulin.The customer was able to troubleshoot during the call.The customer reported that the infusion set cannula was bent upon removal.The infusion set is expected to be returned.

• Brand Name: INFST MM T-975T MIO 2PK 9MM 32IN CLEAR
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 7300654
• MDR Text Key: 101081744
• Report Number: 2032227-2018-01675
• Device Sequence Number: 1
• Product Code: FPA
• 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: 02/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-975T
• Device Catalogue Number: MMT-975T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/24/2018
• Initial Date FDA Received: 02/27/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 43 YR
• Patient Weight: 75