MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM QUICK SET MMT-399T; SET, ADMINISTRATION, INTRAVASCULAR

Model Number MMT-399T

Device Problems Bent (1059); Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/03/2017

Event Type  malfunction  

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

Customer reported that they observed broken infusion set needles on 4 infusion sets.Customer reported that the infusion set fracture was observed when removing products from original packaging.Customer reports that needles were bent a 90-degree angle.Customer also reported experiencing difficulty removing the top from the casing.Troubleshooting was performed.Customer's blood glucose was 84 mg/dl at time of call.Product is not expected to be returned.

• Brand Name: PARADIGM QUICK SET MMT-399T
• 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: 6985688
• MDR Text Key: 90797631
• Report Number: 2032227-2017-62575
• 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: 10/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-399T
• Device Catalogue Number: MMT-399T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/03/2017
• Initial Date FDA Received: 10/27/2017
• 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 Age: 45 YR
• Patient Weight: 68