MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722LNAS; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-722LNAS
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	06/12/2017
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.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.
Event or Problem Description
The customer reported that her infusion sets are detaching.The customer states that she inserts and her pants touch the tubing and it detaches.The customer states that she has high blood sugar and ketones and will be going to the hospital.But then decided later that she will try and treat her high blood sugar herself or go to a clinic instead of the hospital.The customer states that on (b)(6) 2017 her blood sugar started going high and bolusing was not helping due to detachment so she started giving herself injections.Troubleshooting was performed.The customer's blood sugar is 497 mg/dl.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722LNAS
• Common Device Name: PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• MDR Report Key: 6712766
• Report Number: 2032227-2017-28470
• Device Sequence Number: 16276538
• Product Code: OYC
• UDI-Device Identifier: 00613994287212
• UDI-Public: (01)00613994287212
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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
• Report Date (Section B): 07/13/2017

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
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-722LNAS
• Device Catalogue Number: MMT-722LNAS
• Device Lot Number: A000097952
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2017
• Initial Report FDA Received Date: 07/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 29 YR
• Patient Weight: 200