MAUDE Adverse Event Report: MEDTRONIC MINIMED MMT-100 IPORT 10PK NEEDLE 6MM

Model Number MMT-100

Device Problem Leak/Splash (1354)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912)

Event Date 05/17/2017

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

It was reported that the insulin was coming out of the top of the septum of the iport.The customer's blood glucose was 48 mg/dl and has already treated.Customer stated the same type of needle was was used with the previous iport and it worked fine.Customer was still wearing the iport.The customer's blood glucose was 232 mg/dl at the time of call.Customer will treat with pen.The product was not returned.

Manufacturer Narrative

The case(b)(4) was reported in error.

• Brand Name: MMT-100 IPORT 10PK NEEDLE 6MM
• 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: 6643499
• MDR Text Key: 77828940
• Report Number: 2032227-2017-21036
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244009394
• UDI-Public: (01)05705244009394(017)20200101(10)5177305
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/01/2020
• Device Model Number: MMT-100
• Device Catalogue Number: MMT-100
• Device Lot Number: 5177305
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other