MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM QUICKSERTER; KZH

Model Number MMT-395

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Hyperglycemia (1905)

Event Date 10/11/2014

Event Type  malfunction  

Event Description

While reporting blood at the insertion site and trouble with serter releasing the sensor, customer reported that she had a blood glucose level of 419 mg/dl.No further information was provided.

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.

• Brand Name: PARADIGM QUICKSERTER
• Type of Device: KZH
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire street; northridge CA 91325
• Manufacturer (Section G): MEDTRONIC MINIMED; 18000 devonshire street; northridge CA 91325 121
• Manufacturer Contact: christopher tupper ; 18000 devonshire street; northridge, CA 91325-1219 ; 8185764313
• MDR Report Key: 4240664
• MDR Text Key: 5060727
• Report Number: 2032227-2014-49778
• Device Sequence Number: 1
• Product Code: KZH
• Combination Product (y/n): N
• PMA/PMN Number: K992300
• 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: 10/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-395
• Device Catalogue Number: MMT-395
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 43 YR
• Patient Weight: 119