MAUDE Adverse Event Report: MEDTRONIC MINIMED MEDTRONIC MINIMED QUICKSET INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number MMT-397

Device Problem Insufficient Information (3190)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912)

Event Date 05/05/2017

Event Type  Injury  

Event Description

The pt stated that he had 3 hospitalizations during the time span beginning on (b)(6) to the present.He said that he had both hyperglycemic and hypoglycemic events during this time frame.

• Brand Name: MEDTRONIC MINIMED QUICKSET INFUSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): MEDTRONIC MINIMED; northridge CA
• MDR Report Key: 6864473
• MDR Text Key: 86160743
• Report Number: MW5072126
• 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: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: MMT-397
• Device Lot Number: 5171622
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 60 YR
• Patient Weight: 100