MAUDE Adverse Event Report: MEDTRONIC MINIMED SOF SET MIRCO QR; FPA

Model Number MMT-325

Device Problem Bent (1059)

Patient Problems Erythema (1840); Hyperglycemia (1905); Scar Tissue (2060)

Event Date 03/13/2017

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

It was reported via phone call that customer experienced blood at site and bent cannula.Customer's blood glucose was 430 mg/dl.Troubleshooting was performed and customer reported of having scar tissue and site was red, but no longer showed signs of infection.Customer was educated on the causes and prevention of bent cannula.Customer changed site and was advised to monitor issue.

• Brand Name: SOF SET MIRCO QR
• Type of Device: FPA
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire street; northridge CA 91325
• Manufacturer (Section G): MEDTRONIC MINIMED; 18000 devonshire street; northridge CA 91325 1219
• Manufacturer Contact: gerwin de graaff ; 18000 devonshire street; northridge, CA 91325-1219 ; 8185764805
• MDR Report Key: 6409949
• MDR Text Key: 70111800
• Report Number: 2032227-2017-12731
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: K001827
• 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: 03/13/2017

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-325
• Device Catalogue Number: MMT-325
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/13/2017
• Initial Date FDA Received: 03/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other
• Patient Age: 23 YR
• Patient Weight: 83