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

Model Number	MMT-722RNAS
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	09/26/2017
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 via phone call that they were hospitalized on (b)(6) 2017 due to car accident and low and high blood glucose.The blood glucose was 169 mg/dl.Customer reported about 6 months ago he was hospitalized for high with blood glucose over 1500 mg/dl at time of admission.The first time was when his wife passed away.He was not paying attention and crashed the car and went into a coma.Then customer's house was burglarized.First hospitalization for blood sugar related (b)(6) 2016.That is when customer crashed the car.Customer does not know what it was.He just was not paying attention because his wife died and he was more concerned about that.Then customer also had 9 heart attacks.Customer is currently on pen and has to eat constantly to keep blood glucose up.Customer wearing the pump at time of hospitalization.Customer had 5 strokes while in hospital.Customer was in hospital for a month.He was treated for low blood glucose and high blood glucose.Customer stated he was in the hospital (b)(6) 2017 for a low blood glucose of 22 mg/dl but was not wearing the pump at the time and was on injections.He stated he has a hard time while on injections maintaining blood glucose.The insulin pump will not be returned for analysis.
Additional Manufacturer Narrative
The information provided that the date of event with the initial report was incorrect.The correct information has been included with this report.
Event or Problem Description
Incident date has been changed to (b)(6) 2017.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722RNAS
• 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: 7004415
• Report Number: 2032227-2017-64068
• Device Sequence Number: 11062154
• Product Code: OYC
• UDI-Device Identifier: 00613994623935
• UDI-Public: (01)00613994623935
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 07/11/2018

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-722RNAS
• Device Catalogue Number: MMT-722RNAS
• Device Lot Number: A000142622
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/26/2017
• Supplement Date Received by Manufacturer: 10/26/2017
• Initial Report FDA Received Date: 11/06/2017
• Supplement Report FDA Received Date: 07/12/2018
• 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: Hospitalization; Life Threatening
• Patient Age: 77 YR
• Patient Weight: 160