MAUDE Adverse Event Report: MEDTRONIC MINIMED GUIDE MMT-100T IPORT 2PK NEEDLE 6MM

Model Number	MMT-100T
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/06/2017
Type of Reportable Event	Serious Injury
Additional 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.The device will be returned for analysis and further information will follow once the analysis has been completed.No conclusion can be drawn at this time.
Event or Problem Description
The customer's mother reported via phone call that they experienced high blood glucose level of 488 mg/dl.The customer is using an iport and is having high blood glucose.Per the customer's mother the customer received the iport as sample, this is the first time using it and that the site does not look damage and fully inserted into the skin however, after the iport was removed found the cannula was bent.The product will be returned for analysis.
Additional Manufacturer Narrative
The case-(b)(4) was reported in error.

• Brand Name: GUIDE MMT-100T IPORT 2PK NEEDLE 6MM
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• MDR Report Key: 6611250
• Report Number: 2032227-2017-20674
• Device Sequence Number: 12448
• Product Code: OYC
• UDI-Device Identifier: 05705244009356
• UDI-Public: (01)05705244009356(017)20200201
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2017

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/01/2020
• Device Model Number: MMT-100T
• Device Catalogue Number: MMT-100T
• Device Lot Number: 5180544
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/06/2017
• Supplement Date Received by Manufacturer: 05/06/2017
• Initial Report FDA Received Date: 06/05/2017
• Supplement Report FDA Received Date: 08/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 9 YR
• Patient Weight: 82