MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723LNAL; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-723LNAL
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Material Integrity Problem (2978); Patient Device Interaction Problem (4001); Priming Problem (4040)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	01/12/2019
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 experienced hyperglycemia.The customer stated that in january their blood glucose level was over 500 and woke up with 578 mg/dl then went to hospital.Customer reported that the infusion set head was broken but insulin pump did not gave him no delivery alarm.Customer also stated that the insulin pump rejected new batteries.Customer stated that the insulin was squirted out during priming.Customer was on intravenous insulin at the hospital.Customer stated that the insulin pump was working as it should.Customer got home from work at 11 pm and had 10 carbohydrates and gave bolus with a blood glucose at 93 mg/dl.Customer declined to troubleshoot for any issues at this moment.The insulin pump will not be returned for analysis.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723LNAL
• 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: 8900599
• Report Number: 2032227-2019-47729
• Device Sequence Number: 2206788
• Product Code: OYC
• UDI-Device Identifier: 00613994904508
• UDI-Public: (01)00613994904508
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/16/2019

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-723LNAL
• Device Catalogue Number: MMT-723LNAL
• Device Lot Number: A000202977
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2019
• Initial Report FDA Received Date: 08/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNOMED INF SET, FRN-UNK-RSVR
• Outcome Attributed to Adverse Event: Other
• Patient Age: 67 YR
• Patient Weight: 76