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

Model Number	MMT-723RNAP
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	06/15/2018
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
It was reported that the insulin pump had a low blood glucose value of 38 mg/dl at the time of the incident.The customer treated with a glucose tablet.The customer also stated the insulin pump had physical damage.No troubleshooting was performed for the low blood glucose value.Troubleshooting for damage resulted in the insulin pump being replaced and returned.
Additional Manufacturer Narrative
Device had cracked lcd window, cracked case at display window corner.The information provided that the date of event with the initial report was incorrect.The correct information has been included with this report.The information provided in the section of concomitant product 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), 2018.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723RNAP
• 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: 7688139
• Report Number: 2032227-2018-08236
• Device Sequence Number: 1316126
• Product Code: OYC
• UDI-Device Identifier: 00613994904393
• UDI-Public: (01)00613994904393
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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,Followup,Followup
• Report Date (Section B): 10/30/2018

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-723RNAP
• Device Catalogue Number: MMT-723RNAP
• Device Lot Number: A000204715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2018
• Initial Date Received by Manufacturer: 06/15/2018
• Supplement Date Received by Manufacturer: 06/15/2018; 10/24/2018
• Initial Report FDA Received Date: 07/13/2018
• Supplement Report FDA Received Date: 09/13/2018; 10/30/2018
• 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: Other
• Patient Age: 46 YR
• Patient Weight: 147